[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Notices]
[Pages 4088-4098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00787]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

RIN 0991-ZA52


Making Permanent Regulatory Flexibilities Provided During the 
COVID-19 Public Health Emergency by Exempting Certain Medical Devices 
From Premarket Notification Requirements; Request for Information, 
Research, Analysis, and Public Comment on Opportunities for Further 
Science and Evidence-Based Reform of Section 510(k) Program

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Notice; request for information.

-----------------------------------------------------------------------

SUMMARY: To provide Americans with expanded access to certain medical 
devices to respond to the COVID-19 Public Health Emergency, FDA issued 
guidance documents providing numerous regulatory flexibilities, 
including a temporary waiver of premarket notification requirements 
under section 510(k) of the Food, Drug, and Cosmetic Act. For seven 
class I devices for which 510(k) premarket review as temporarily waived 
during the PHE, the Department of Health and Human Services is 
permanently exempting those seven (7) class I devices from the 510(k) 
requirement and is also proposing to exempt an additional 83 class II 
devices and 1 unclassified device class from the 510(k) requirement, 
for which premarket review had also been waived during the PHE. The 
Department is soliciting the public's views on whether premarket review 
should be permanently waived for some or all of these 83 devices and 
views on ways to improve the 510(k) premarket notification program.

DATES: Part III.A of this Notice shall be effective immediately on 
publication in the Federal Register. To be considered, responses and 
comments related to Part III.B of this Notice must be received 
electronically, within sixty days of publication in the Federal 
Register as provided below. The Department will consider information 
submitted by the public in response to Part IV of this Notice on a 
rolling basis, and until further notice.

ADDRESSES: You may submit comments through the Federal eRulemaking 
Portal: http://www.regulations.gov. Follow the instructions for 
submitting comments.
    Instructions: All submissions received must include the agency name 
and docket number or Regulatory Information Number (RIN) for this 
rulemaking. All comments received will be posted to http://regulations.gov, including any personal information provided. For 
access to the docket to read background documents or comments received, 
go to http://www.regulations.gov. Comments must be identified by 0991-
ZA52. Because of staff and resource limitations, all comments must be 
submitted electronically to www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    Warning: Do not include any personally identifiable information 
(such as name, address, or other contact information) or confidential 
business information that you do not want publicly disclosed. All 
comments may be posted on the internet and can be retrieved by most 
internet search engines. No deletions, modifications, or redactions 
will be made to comments received.
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including personally identifiable or confidential business information 
that is included in a comment. You may wish to consider limiting the 
amount of personal information that you provide in any voluntary public 
comment submission you make. HHS may withhold information provided in 
comments from public viewing that it determines may impact the privacy 
of an individual or is offensive. For additional information, please 
read the Privacy Act notice that is available via the link in the 
footer of http://www.regulations.gov. Follow the search instructions on 
that website to view the public comments.

FOR FURTHER INFORMATION CONTACT: Dan Barry, 200 Independence Ave. SW, 
Washington, DC 20201; or by email at daniel.barry@hhs.gov; or by 
telephone at 1-877-696-6775.

SUPPLEMENTARY INFORMATION: The Administration is committed to creating 
a data-based regulatory process that appropriately balances benefits 
and costs. Consistent with the President's executive order on COVID-19 
regulatory flexibilities, and Congress' direction in the 21st Century 
Cures Act, the Department is issuing this Notice to permanently exempt 
or proposing to permanently exempt certain class I and class II medical 
devices from the premarket notification requirement in section 510(k) 
of the Food, Drug, and Cosmetic Act, 21 U.S.C. 360(k). Under this 
notice, the Department is immediately making permanent the exemption of 
7 class I device classes from the section 510(k) requirement and 
proposes to exempt an additional 84 class II and unclassified device 
classes from the same requirement on a permanent basis. These 91 
devices were all subject a 510(k) waiving during the PHE.

I. Background

A. Statutory Framework

    Under the Food, Drug, and Cosmetic Act (FD&C Act), medical devices 
are placed ``in three categories based on the risk that they pose to 
the public.'' \1\ Class I devices, products ``that present no 
unreasonable risk of illness or injury,'' \2\ are subject to general 
controls. FD&C Act 513(a)(1)(A), 21 U.S.C.

[[Page 4089]]

360c(a)(1)(A). Class II devices are ``potentially more harmful'' than 
class I devices, and ``must comply with federal performance regulations 
known as `special controls.''' \3\ Class III devices carry the highest 
risk, in that they are for ``use in supporting or sustaining human life 
or for a use which is of substantial importance in preventing 
impairment of human health, or present[ ] a potential unreasonable risk 
of illness or injury.'' FD&C Act 513(a)(1)(C)(ii)(I)-(II), 21 U.S.C. 
360c(a)(1)(C)(ii)(I)-(II).
---------------------------------------------------------------------------

    \1\ Medtronic, Inc. v. Lohr, 518 U.S. 470, 476 (1996).
    \2\ Id. at 476-77.
    \3\ Lohr, 518 U.S. at 477; see also FD&C Act 513(a)(1)(B), 21 
U.S.C. 360c(a)(1)(B).
---------------------------------------------------------------------------

    Medical devices are generally subject to FDA premarket review in 
one of two forms. The first is premarket approval (PMA) review under 
section 515 of the FD&C Act, 21 U.S.C. 360e. This form of ``rigorous'' 
review, analogous to FDA review of a New Drug Application for a ``new 
drug,'' requires manufacturers to ``submit detailed information 
regarding the safety and efficacy of their devices, which the FDA then 
reviews.'' \4\ During the mid-1990s, FDA reported spending ``an average 
of 1,200 hours on each [PMA] submission,'' \5\ though the time for 
review has likely increased since Lohr was decided.
---------------------------------------------------------------------------

    \4\ Lohr, 518 U.S. at 477.
    \5\ Id.
---------------------------------------------------------------------------

    The second form of premarket review is the premarket notification 
process, which is commonly referred to as the 510(k) process after 
section 510(k) of the FD&C Act, 21 U.S.C. 360(k). Generally, under the 
510(k) process, a device that is ``substantially equivalent'' to 
another legally marketed predicate device is ``cleared'' (as opposed to 
``approved'') \6\ by FDA for legal marketing in the United States. See 
FD&C Act 510(k), 513(i), 21 U.S.C. 360(k), 360c(i). FDA regulations 
specify the required contents of 510(k) notifications, including 
labeling, intended use, and clinical and performance data requirements. 
21 CFR 807.92. FDA previously reported requiring ``an average of only 
20 hours'' to complete a 510(k) review,\7\ which would be around 60 
times less than the time required for PMA review.
---------------------------------------------------------------------------

    \6\ See 21 CFR 807.97 (providing that ``determination by the 
Commissioner that the device intended for introduction into 
commercial distribution is substantially equivalent'' to a predicate 
device ``does not in any way denote official approval of the 
device'').
    \7\ Id.
---------------------------------------------------------------------------

    Obtaining either a PMA approval or a 510(k) clearance to legally 
market a medical device is expensive and time-consuming. According to a 
2010 survey of medical device companies, ``the average total cost from 
concept to approval [of a PMA device] was approximately $94 million, 
with $75 million spent on stages linked to the FDA.'' \8\ For PMAs, 
survey respondents reported ``that it actually took them an average of 
54 months to work with the FDA from first communication to approval.'' 
\9\
---------------------------------------------------------------------------

    \8\ Josh Makower, Aabed Meer & Lyn Denend, FDA Impact on U.S. 
Medical Technology Innovation: A Survey of Over 200 Medical Device 
Companies, at 7 (Nov. 2010), https://www.medtecheurope.org/wp-content/uploads/2015/07/01112010_FDA-impact-on-US-medical-technology-innovation_Backgrounder.pdf. During a 2011 hearing before 
a House subcommittee, the Director for the Center for Devices and 
Radiological Health (CDRH) raised concerns regarding the methodology 
used in this study. FDA Medical Device Approval: Is There a Better 
Way?, Hearing Before the H. Subcomm. on Health Care, District of 
Columbia, Census and the National Archives, 112th Cong. 29 (2011) 
(hereinafter the ``2011 Hearing''). The CDRH Director's criticisms 
largely focused on the report's comparison of FDA's regulation of 
medical devices to the European Union's regulatory system. The CDRH 
Director otherwise acknowledged that FDA does not ``do cost analyses 
for what the manufacturers are doing'' and that the agency ``would 
not know of the total cost to a particular company.'' Id. at 32. 
Here, the Department is citing this study for 510(k) cost and time 
estimates, not for purposes of comparing the U.S. and E.U. medical 
device regulatory systems.
    \9\ Id. at 22.
---------------------------------------------------------------------------

    While 510(k) devices trod a swifter, less expensive path to market 
than PMA devices do, the same survey found that ``the average total 
cost for participants to bring a low-to-moderate-risk 510(k) product 
from concept to clearance was approximately $31 million, with $24 
million spent on FDA dependent and/or related activities.'' \10\ 
Respondents also reported ``an average of 10 months from first filing 
to clearance'' for a 510(k) device.\11\ The survey authors acknowledged 
that respondents ``were most likely those companies working on 
innovative, new medical technologies that required clinical data to get 
through the FDA rather those seeking relatively simple extensions to 
low-risk, ubiquitous product lines already in existence.'' \12\ 
Nevertheless, the survey found the average total cost connected to the 
``Process of Obtaining [a] 510(k) [clearance]'' to be more than $4 
million per product.\13\ Even if these estimates overstate costs by a 
factor of ten, a firm could still spend $2.4 million ``on FDA dependent 
and/or related activities,'' to include an estimated $400,000 on the 
510(k) clearance process itself. Similarly, even if the survey 
respondents overstated delays, and the actual time were much closer to 
FDA's goal date of 90 days for review, it is undisputed that the 510(k) 
clearance process delays a device's introduction to the market.
---------------------------------------------------------------------------

    \10\ Id. at 7.
    \11\ Id. at 22.
    \12\ Id. at 29, fig. 10.
    \13\ Id.
---------------------------------------------------------------------------

    A 2014 report on antibacterial products produced for the Assistant 
Secretary for Planning and Evaluation (ASPE) contains similar findings. 
The report noted that, to conduct a pivotal clinical study to support a 
510(k) submission for a MRSA point-of-care diagnostic, a manufacturer 
could expect to spend ``from a low of $250,000 to as high as $4.0 
million.'' \14\ The report estimated the cost to prepare and submit a 
510(k) application ``at $100,000'' while acknowledging the amount 
``could be highly variable depending on device characteristics.'' \15\
---------------------------------------------------------------------------

    \14\ Aylin Sertkaya et al., Analytical Framework for Examining 
the Value of Antibacterial Products, at 5-3 (Apr. 15, 2014).
    \15\ Id. at 5-4.
---------------------------------------------------------------------------

    These costs are barriers to new market entrants. To the extent 
imposing the section 510(k) premarket notification on a device does not 
create corresponding safety and efficacy benefits for Americans, those 
barriers are unjustified. Such barriers warrant scrutiny, particularly 
when market incumbents have an interest in retaining them. As FDA 
acknowledged in a 1975 proposed rule in the analogous context of drug 
approvals, ``the manufacturer who holds the `pioneer' NDA for a drug 
may well have an economic interest in retaining the new drug status of 
that drug'' because ``[a]s long as either a full or an abbreviated NDA 
is required, entry into the market place, and thus increased 
competition is impeded.'' \16\ FDA noted its belief ``that it was not 
the intention of Congress that section 505 of the [FD&C Act] would be 
used as an economic trade barrier.'' \17\
---------------------------------------------------------------------------

    \16\ 40 FR 26142, 26148 (June 20, 1975).
    \17\ Id.

---------------------------------------------------------------------------

[[Page 4090]]

    Congress has taken action to ensure that the section 510(k) 
premarket notification process does not create undue economic barriers 
for new medical devices. Under the FD&C Act, the Secretary is 
authorized to exempt class I and II medical devices from the 510(k) 
requirement if the Secretary finds those devices ``no longer require[ ] 
a report under section [510](k) to provide reasonable assurance of 
safety and effectiveness.'' FD&C Act 510(l)(2), 510(m)(1)(A)(i), 21 
U.S.C. 360(l)(2), 360(m)(1)(A)(i). Congress did this in part to ``allow 
the Secretary to expend limited premarket review resources on 
potentially risky and technologically advanced devices'' so that ``the 
public continues to be adequately protected and will still benefit from 
the earlier availability of new products.'' \18\ In section 3054 of the 
21st Century Cures Act, Public Law 114-255, 130 Stat. 1033, 1126-27 
(Dec. 13, 2016), Congress imposed additional requirements on the 
Secretary to take action to affirmatively review class I and II devices 
to determine whether they are exempt from the 510(k) requirement. This 
Notice is responsive to these previous mandates.
---------------------------------------------------------------------------

    \18\ H.R. Conf. Rep. 105-399, at 96 (1997).
---------------------------------------------------------------------------

B. Waiver of Premarket Notification Requirement During COVID-19 PHE

    Beginning in March 2020, in response to the COVID-19 Public Health 
Emergency (PHE), FDA issued a series of guidance documents designed to 
provide the private sector with regulatory flexibility to meet the 
sudden, increased need for personal protective equipment, disinfectant 
products, and other devices to combat the pandemic. The table below 
presents the various guidance documents issued in April 2020 to assist 
in the response to the PHE.

 Table 1--List of FDA Medical Device Enforcement Policies Responsive to
                                   PHE
------------------------------------------------------------------------
              Title of guidance                           Date
------------------------------------------------------------------------
Enforcement Policy for Clinical Electronic     April 2020.
 Thermometers During the Coronavirus Disease
 2019 (COVID-19) Public Health Emergency.
Enforcement Policy for Imaging Systems During  April 2020.
 the Coronavirus Disease 2019 (COVID-19)
 Public Health Emergency.
Enforcement Policy for Face Masks and          May 2020.
 Respirators During the Coronavirus Disease
 (COVID-19) Public Health Emergency (Revised).
Enforcement Policy for Gowns, Other Apparel,   March 2020.
 and Gloves During the Coronavirus Disease
 (COVID-19) Public Health Emergency.
Enforcement Policy for Sterilizers,            March 2020.
 Disinfectant Devices, and Air Purifiers
 During the Coronavirus Disease 2019 (COVID-
 19) Public Health Emergency.
Enforcement Policy for Digital Health Devices  April 2020.
 For Treating Psychiatric Disorders During
 the Coronavirus Disease 2019 (COVID-19)
 Public Health Emergency.
Enforcement Policy for Extracorporeal          April 2020.
 Membrane Oxygenation and Cardiopulmonary
 Bypass Devices During the Coronavirus
 Disease 2019 (COVID-19) Public Health
 Emergency.
Enforcement Policy for Infusion Pumps and      April 2020.
 Accessories During the Coronavirus Disease
 2019 (COVID-19) Public Health Emergency.
Enforcement Policy for Non-Invasive Fetal and  April 2020.
 Maternal Monitoring Devices Used to Support
 Patient Monitoring During the Coronavirus
 Disease 2019 (COVID-19) Public Health
 Emergency.
Enforcement Policy for Non-Invasive Remote     March 2020 (original).
 Monitoring Devices Used to Support Patient    June 2020 (revised).
 Monitoring During the Coronavirus Disease-    October 2020 (revised).
 2019 (COVID-19) Public Health Emergency
 (Revised).
Enforcement Policy for Remote Digital          April 2020.
 Pathology Devices During the Coronavirus
 Disease 2019 (COVID-19) Public Health
 Emergency.
Enforcement Policy for Remote Ophthalmic       April 2020.
 Assessment and Monitoring Devices During the
 Coronavirus Disease 2019 (COVID-19) Public
 Health Emergency.
Enforcement Policy for Ventilators and         March 2020.
 Accessories and Other Respiratory Devices
 During the Coronavirus Disease 2019 (COVID-
 19) Public Health Emergency.
------------------------------------------------------------------------

    As FDA explained in its clinical thermometer guidance, FDA provided 
these flexibilities to ``ensure the availability of equipment that 
might offer some benefit to health care providers and the general 
public during the public health emergency.'' \19\ To that end, among 
other things, FDA announced that the agency ``does not intend to object 
to the distribution and use of clinical thermometers that are not 
currently 510(k) cleared.'' \20\ Some of the flexibilities, such as 
those extended to remote patient monitoring, have helped facilitate 
telemedicine during the PHE. FDA extended similar flexibility to 
additional devices in other guidance documents shown in Table 1.
---------------------------------------------------------------------------

    \19\ FDA, Enforcement Policy for Clinical Electronic 
Thermometers During the Coronavirus Disease 2019 (COVID-19) Public 
Health Emergency, at 3 (Apr. 2020), https://www.fda.gov/media/136698/download.
    \20\ Id.
---------------------------------------------------------------------------

II. HHS' Review of 510(k) Premarket Notification Flexibilities

    On May 19, 2020, the President issued Executive Order No. 13924, 
instructing ``[t]he heads of all agencies'' to ``review any regulatory 
standards that they have temporarily rescinded, suspended, modified, or 
waived during the public health emergency,'' in order to ``determine 
which, if any, would promote economic recovery if made permanent.'' 
\21\ Further, Congress already instructed the Secretary to consider 
whether to exempt class I and II devices from the section 510(k) 
requirement ``at least once every 5 years.'' FDCA 510(l)(2), 
510(m)(1)(A), 21 U.S.C. 360(l)(2), 360(m)(1)(A).
---------------------------------------------------------------------------

    \21\ 85 FR 31353, 31356 (May 22, 2020).
---------------------------------------------------------------------------

    Consistent with the President's executive order, and Congress' 
direction in the 21st Century Cures Act, the Department conducted a 
data-driven review to determine whether temporary waiver of the section 
510(k) premarket notification requirement for some devices during the 
PHE should be made permanent. The flexibilities given by FDA during the 
PHE presented the Department with a unique opportunity to analyze the 
adverse event records of

[[Page 4091]]

devices in periods of time with and without the premarket notification 
requirement. In view of this, the overarching question for HHS was 
whether premarket notification provided corresponding safety and 
efficacy benefits. Below the Department describes the methodology for 
its review and the results of the same.

A. Methodology

    HHS first reviewed the thirteen FDA guidance documents listed in 
Table 1 to determine which device types are subject to those 
enforcement policies. The Department identified 221 unique device 
types. HHS analyzed those device types using FDA's Product Code 
Database \22\ to determine how many of those devices require premarket 
review. Of those 221 device types, the Department determined that 5 
require a PMA, 29 are exempt from the 510(k) requirement, 3 are 
marketed subject to FDA's enforcement discretion, and 184 require 
510(k) clearance prior to marketing. Of the 184 devices types that 
would require 510(k) clearance without the guidance documents list in 
Table 1, 10 are class I devices, 173 are class II devices, and 1 is 
unclassified. These 184 devices are referred to collectively in this 
Notice as the ``Review Devices.''
---------------------------------------------------------------------------

    \22\ FDA, Product Classification Database, https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database.
---------------------------------------------------------------------------

    FDA maintains a publicly available adverse event reporting database 
called the Manufacturer and User Facility Device Experience database or 
MAUDE. MAUDE ``houses [medical device reports or] MDRs submitted to the 
FDA by mandatory reports (manufacturers, importers and device user 
facilities) and voluntary reporters such as health care professionals, 
patients and consumers.'' \23\ Like any ``passive surveillance 
system,'' MAUDE has ``limitations, including the potential submission 
of incomplete, inaccurate, untimely, or biased data,'' which means 
``incidence or prevalence of an event cannot be determined from this 
reporting system alone due to under-reporting of events, inaccuracies 
in reports, lack of verification that the device caused the reported 
event, and lack of information about frequency of device use.'' \24\ 
Even with the system's limitations, MAUDE is an important source of 
data. FDA has previously used data from MAUDE to inform the agency's 
decision making.\25\ Products liability plaintiffs also make use of the 
database.\26\ As the CDRH Director previously explained to Congress, 
systems like MAUDE set the United States apart from jurisdictions like 
the European Union that ``do not have publicly available centralized 
data base[s] for that kind of information.'' \27\
---------------------------------------------------------------------------

    \23\ FDA, MAUDE--Manufacturer and User Facility Device 
Experience, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm.
    \24\ Id.
    \25\ E.g., 85 FR 70003, 70006 (Dec. 20, 2019).
    \26\ See Patrick J. McGrather, The FDA's MAUDE: Useful Insights 
for Medical Devices (Oct. 31, 2017), https://www.americanbar.org/groups/litigation/committees/mass-torts/practice/2017/manufacture-and-user-facility-device-experience/.
    \27\ 2011 Hearing at 30.
---------------------------------------------------------------------------

    In this review, the Department performed searches of the Review 
Devices in FDA's online searchable MAUDE database. Updated on a monthly 
basis, the online ``searchable database data contains the last 10 
year's data'' of reports ``on medical devices which may have 
malfunctioned or caused a death or serious injury.'' \28\ HHS entered 
the three-letter product code for each Review Device into the online 
MAUDE database. HHS then collected data on the number of reports for 
each Review Device from November 1, 2010 to November 30, 2020, 
tabulating the reports from November 1, 2010 to the beginning of the 
PHE, and for the time period subsequent the beginning of the PHE to 
November 30, 2020.
---------------------------------------------------------------------------

    \28\ FDA, Manufacturer and User Facility Device Experience 
Database--(MAUDE), https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/manufacturer-and-user-facility-device-experience-database-maude.
---------------------------------------------------------------------------

B. Results

    Of the 184 Review Devices, HHS found there were 120 or more MAUDE 
reports for 74 devices and less than 100 MAUDE reports for the 110 
other devices during the last ten years. This means roughly 60% of the 
Review Devices have less than 100 MAUDE reports over the last ten 
years. Of those 110 devices, 35 devices had no MAUDE reports from 
November 1, 2010 to November 30, 2020. Those 35 devices are shown in 
Table 2 below.

    Table 2--Review Devices With Zero Adverse Event Reports in MAUDE for the Time Period November 1, 2010 to
                                                November 30, 2020
----------------------------------------------------------------------------------------------------------------
                                                                                                   Section in 21
           Device description                      Device class                Product code             CFR
----------------------------------------------------------------------------------------------------------------
Powder-Free Polychloroprene Patient      I..............................  OPC...................        880.6250
 Examination Glove.
Ventilator, Continuous, Minimal          II.............................  NQY...................        868.5895
 Ventilatory Support, Home Use.
Airway Monitoring System...............  II.............................  OQU...................        868.5730
Impedance Measuring Device Utilizing     II.............................  PNV...................        868.1840
 Oscillation Techniques.
Gauge, Pressure, Coronary,               II.............................  DXS...................        870.4310
 Cardiopulmonary Bypass.
Valve, Pressure Relief, Cardiopulmonary  II.............................  MNJ...................        870.4400
 Bypass.
Oximeter, Tissue Saturation,             II.............................  NMD...................        870.2700
 Reprocessed.
Multivariate Vital Signs Index.........  II.............................  PLB...................        870.2300
Electrocardiograph Software For Over-    II.............................  QDA...................        870.2345
 The-Counter Use.
Sterilizer, Dry Heat...................  II.............................  KMH...................        880.6870
Check Valve, Retrograde Flow (In-Line).  II.............................  MJF...................        880.5440
Intravascular Administration Set,        II.............................  OKL...................        880.5445
 Automated Air Removal System.
Neuraxial Administration Set--           II.............................  PYR...................        880.5440
 Intrathecal Delivery.
High Level Disinfection Reprocessing     II.............................  PSW...................        892.1570
 Instrument For Ultrasonic Transducers,
 Liquid.
Pediatric/Child Facemask...............  II.............................  OXZ...................        878.4040
Normalizing Quantitative                 II.............................  OLU...................        882.1400
 Electroencephalograph Software.
Computerized Cognitive Assessment Aid..  II.............................  PKQ...................        882.1470
Physiological Signal Based Seizure       II.............................  POS...................        882.1580
 Monitoring System.
Computerized Behavioral Therapy Device   II.............................  PWE...................        882.5801
 For Psychiatric Disorders.
Monitor, Phonocardiographic, Fetal.....  II.............................  HFP...................        884.2640
Monitor, Cardiac, Fetal................  II.............................  KXN...................        884.2600
Digital Pathology Display..............  II.............................  PZZ...................        864.3700
Digital Pathology Image Viewing And      II.............................  QKQ...................        864.3700
 Management Software.

[[Page 4092]]

 
System, Imaging, Holography, Acoustic..  II.............................  NCS...................        892.1550
Lung Computed Tomography System,         II.............................  OEB...................        892.2050
 Computer-Aided Detection.
Chest X-Ray Computer Aided Detection...  II.............................  OMJ...................        892.2050
Computer-Assisted Diagnostic Software    II.............................  POK...................        892.2060
 For Lesions Suspicious For Cancer.
Radiological Computer-Assisted Triage    II.............................  QAS...................        892.2080
 And Notification Software.
Radiological Computer Assisted           II.............................  QBS...................        892.2090
 Detection/Diagnosis Software For
 Fracture.
Radiological Computer Assisted           II.............................  QDQ...................        892.2090
 Detection/Diagnosis Software For
 Lesions Suspicious For Cancer.
Radiological Computer-Assisted           II.............................  QFM...................        892.2080
 Prioritization Software For Lesions.
X-Ray Angiographic Imaging Based         II.............................  QHA...................        892.1600
 Coronary Vascular Simulation Software
 Device.
Automated Radiological Image Processing  II.............................  QIH...................        892.2050
 Software.
Image Acquisition And/Or Optimization    II.............................  QJU...................        892.2100
 Guided By Artificial Intelligence.
Apparatus, Vestibular Analysis.........  Unclassified...................  LXV...................             N/A
----------------------------------------------------------------------------------------------------------------

    Another 43 devices had no reports in MAUDE following declaration of 
the PHE, and the waiver of the 510(k) premarket notification 
requirement, with anywhere from 1 to 86 reports in MAUDE prior to the 
PHE for those same devices. For the ten-year period spanning November 
1, 2010 to November 30, 2020, there were a total of 637 reports in 
MAUDE associated with theses 43 devices listed in Table 3.1. This 
equates to about 1.5 MAUDE reports per year per device. Table 3.1 below 
shows each device with the corresponding number of adverse events 
before and after the PHE.

   Table 3.1--Review Devices with Zero Adverse Events Post-PHE and 86 or Fewer Adverse Events Pre-PHE in MAUDE
----------------------------------------------------------------------------------------------------------------
                                                                                                   MAUDE  events
                                                                      Section in   MAUDE events    Post-PHE  to
       Device description           Device class      Product code      21 CFR      November 1,    November 30,
                                                                                    2010 to PHE        2020
----------------------------------------------------------------------------------------------------------------
Patient Examination Glove,        I...............  LZC............     880.6250              46               0
 Specialty.
Radiation Attenuating Medical     I...............  OPH............     880.6250               1               0
 Glove.
Powder-Free Non-Natural Rubber    I...............  OPA............     878.4460               1               0
 Latex Surgeon's Gloves.
Powder-Free Guayle Rubber         I...............  OIG............     880.6250               2               0
 Examination Glove.
Latex Patient Examination Glove.  I...............  LYY............     880.6250              48               0
Meter, Peak Flow, Spirometry....  II..............  BZH............     868.1860              27               0
Monitor, Apnea, Facility Use....  II..............  FLS............     868.2377              86               0
Monitor, Apnea, Home Use........  II..............  NPF............     868.2377              41               0
Oximeter, Reprocessed...........  II..............  NLF............     870.2700              65               0
Stethoscope, Electronic.........  II..............  DQD............     870.1875               2               0
Defoamer, Cardiopulmonary Bypass  II..............  DTP............     870.4230               4               0
Filter, Blood, Cardiotomy         II..............  JOD............     870.4270               2               0
 Suction Line, Cardiopulmonary
 Bypass.
Detector, Bubble,                 II..............  KRL............     870.4205              44               0
 Cardiopulmonary Bypass.
Cpb Check Valve, Retrograde       II..............  MJJ............     870.4400              12               0
 Flow, In-Line.
Sterilizer, Ethylene-Oxide Gas..  II..............  FLF............     880.6860              29               0
Cabinet, Ethylene-Oxide Gas       II..............  FLI............     880.6100               2               0
 Aerator.
Purifier, Air, Ultraviolet,       II..............  FRA............     880.6500               1               0
 Medical.
Cleaner, Air, Medical             II..............  FRF............     880.5045               7               0
 Recirculating.
Controller, Infusion,             II..............  LDR............     880.5725              27               0
 Intravascular, Electronic.
Cleaners, Medical Devices.......  II..............  MDZ............     880.6992               5               0
Percutaneous, Implanted, Long-    II..............  OMF............     880.5970               9               0
 Term Intravascular Catheter
 Accessory For Catheter Position.
N95 Respirator With               II..............  ORW............     880.6260               1               0
 Antimicrobial/Antiviral Agent
 For Use By The General Public
 In Public Health Medical
 Emergencies.
Two Or More Sterilant Sterilizer  II..............  PJJ............     880.6860               6               0
High Level Disinfection           II..............  OUJ............     892.1570               3               0
 Reprocessing Instrument For
 Ultrasonic Transducers, Mist.
Gown, Patient...................  II..............  FYB............     878.4040               1               0
Surgical Mask With Antimicrobial/ II..............  OUK............     878.4040               1               0
 Antiviral Agent.
Cerebral Oximeter...............  II..............  QEM............     870.2700               2               0
Device, Sleep Assessment........  II..............  LEL............     882.5050               4               0
Standard Polysomnograph With      II..............  OLV............     882.1400               9               0
 Electroencephalograph.
Source Localization Software For  II..............  OLX............     882.1400               2               0
 Electroencephalograph Or
 Magnetoencephalograph.
Automatic Event Detection         II..............  OLZ............     882.1400               1               0
 Software For Polysomnograph
 With Electroencephalograph.
Amplitude-Integrated              II..............  OMA............     882.1400               1               0
 Electroencephalograph.

[[Page 4093]]

 
Automatic Event Detection         II..............  OMB............     882.1400               4               0
 Software For Full-Montage
 Electroencephalograph.
Burst Suppression Detection       II..............  ORT............     882.1400               1               0
 Software For
 Electroencephalograph.
Monitor, Heart Rate, Fetal,       II..............  HEL............     884.2660              12               0
 Ultrasonic.
Transducer, Ultrasonic,           II..............  HGL............     884.2960               6               0
 Obstetric.
Uterine Electromyographic         II..............  OSP............     884.2720               3               0
 Monitor.
Tonometer, Ac-Powered...........  II..............  HKX............     886.1930               1               0
Tonometer, Manual...............  II..............  HKY............     886.1930               8               0
Automated Digital Image Manual    II..............  OEO............     864.1860               1               0
 Interpretation Microscope.
System, X-Ray, Tomographic......  II..............  IZF............     892.1740              35               0
Analyzer, Medical Image.........  II..............  MYN............     892.2070               1               0
C-Arm Fluoroscopic X-Ray System.  II..............  RCC............     892.1650              73               0
----------------------------------------------------------------------------------------------------------------

    The Department further analyzed the details of the MAUDE reports 
listed in Table 3.1. For the 5 class I glove devices listed, there were 
98 reports. As shown in Table 3.2 below, after review of the detailed 
narratives for those 98 reports, they can be broken down into eight 
categories.

                                          Table 3.2--MAUDE Report Breakdown for 5 Class I Devices in Table 3.1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             MAUDE report category
                                                      --------------------------------------------------------------------------------------------------
          Device description (Product Code)             Rip/tear/    Discolor/    Allergy/skin    Not device    Improper
                                                           hole        debris         issue        related        use       Mislabeled    Odor    Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Patient Examination Glove, Specialty (LZC)...........           22           19               4            1            0            0        0       46
Radiation Attenuating Medical Glove (OPH)............            0            0               0            0            1            0        0        1
Powder-Free Non-Natural Rubber Latex Surgeon's Gloves            0            0               1            0            0            0        0        1
 (OPA)...............................................
Powder-Free Guayle Rubber Examination Glove (OIG)....            0            0               2            0            0            0        0        2
Latex Patient Examination Glove (LYY)................            6            7              29            4            0            1        1       48
                                                      --------------------------------------------------------------------------------------------------
    Total............................................           28           26              36            5            1            1        1       98
--------------------------------------------------------------------------------------------------------------------------------------------------------

More than half of the reports (55%) related to material flaws such as 
tears, discoloration, or foreign debris in the gloves. For the 36 
allergic reaction reports, there was only one report connected with a 
hospital visit for which the patient was ultimately monitored and 
discharged. There are 5 MAUDE events from which the report narrative 
does not provide a basis to infer that the device itself caused the 
harm.\29\ None of the 98 reports involved a death.
---------------------------------------------------------------------------

    \29\ For example, there was one MAUDE incident where a user 
reported suffering a third-degree burn after ``pouring boiling 
nitric acid into a beaker and without warning a chemical reaction 
occurred causing acid to spill onto the wrist.'' Nothing in the 
report indicates the gloves themselves caused the burn or otherwise 
exacerbated the burn.
---------------------------------------------------------------------------

    The 38 class II devices listed in Table 3.1 were connected to 
another 539 MAUDE reports. Of those reports, 322 (59.7%) involved 
device malfunctions, 71 (13.2%) involved injuries, 22 (4.1%) involved 
deaths, and 124 (23%) have the event type listed as ``other'' or 
``NA.'' Table 3.3 below provides the breakdown of the 539 MAUDE reports 
by device type.

                     Table 3.3--MAUDE Report Breakdown for 38 Class II Devices in Table 3.1
----------------------------------------------------------------------------------------------------------------
                                                                        MAUDE report category
       Device description           Product  code  -------------------------------------------------------------
                                                      Malfunction    Injury    Death    Other      NA     Total
----------------------------------------------------------------------------------------------------------------
Meter, Peak Flow, Spirometry....  BZH.............              26         1        0        0        0       27
Monitor, Apnea, Facility Use....  FLS.............              52         9       16        9        0       86
Monitor, Apnea, Home Use........  NPF.............              34         5        2        0        0       41
Oximeter, Reprocessed...........  NLF.............              49        14        0        0        2       65
Stethoscope, Electronic.........  DQD.............               1         0        0        1        0        2
Defoamer, Cardiopulmonary Bypass  DTP.............               3         1        0        0        0        4
Filter, Blood, Cardiotomy         JOD.............               1         0        0        1        0        2
 Suction Line, Cardiopulmonary
 Bypass.

[[Page 4094]]

 
Detector, Bubble,                 KRL.............              33         0        0        1       10       44
 Cardiopulmonary Bypass.
Cpb Check Valve, Retrograde       MJJ.............              11         1        0        0        0       12
 Flow, In-Line.
Sterilizer, Ethylene-Oxide Gas..  FLF.............               7         9        0        1       12       29
Cabinet, Ethylene-Oxide Gas       FLI.............               0         2        0        0        0        2
 Aerator.
Purifier, Air, Ultraviolet,       FRA.............               1         0        0        0        0        1
 Medical.
Cleaner, Air, Medical             FRF.............               6         0        0        0        1        7
 Recirculating.
Controller, Infusion,             LDR.............              27         0        0        0        0       27
 Intravascular, Electronic.
Cleaners, Medical Devices.......  MDZ.............               4         0        0        1        0        5
Percutaneous, Implanted, Long-    OMF.............               3         2        0        4        0        9
 Term Intravascular Catheter
 Accessory For Catheter Position.
N95 Respirator With               ORW.............               1         0        0        0        0        1
 Antimicrobial/Antiviral Agent
 For Use By The General Public
 In Public Health Medical
 Emergencies.
Two Or More Sterilant Sterilizer  PJJ.............               0         6        0        0        0        6
High Level Disinfection           OUJ.............               1         1        0        1        0        3
 Reprocessing Instrument For
 Ultrasonic Transducers, Mist.
Gown, Patient...................  FYB.............               0         0        1        0        0        1
Surgical Mask With Antimicrobial/ OUK.............               0         1        0        0        0        1
 Antiviral Agent.
Cerebral Oximeter...............  QEM.............               1         1        0        0        0        2
Device, Sleep Assessment........  LEL.............               4         0        0        0        0        4
Standard Polysomnograph With      OLV.............               7         2        0        0        0        9
 Electroencephalograph.
Source Localization Software For  OLX.............               1         1        0        0        0        2
 Electroencephalograph Or
 Magnetoencephalograph.
Automatic Event Detection         OLZ.............               0         1        0        0        0        1
 Software For Polysomnograph
 With Electroencephalograph.
Amplitude-Integrated              OMA.............               1         0        0        0        0        1
 Electroencephalograph.
Automatic Event Detection         OMB.............               1         0        0        1        2        4
 Software For Full-Montage
 Electroencephalograph.
Burst Suppression Detection       ORT.............               1         0        0        0        0        1
 Software For
 Electroencephalograph.
Monitor, Heart Rate, Fetal,       HEL.............               9         2        1        0        0       12
 Ultrasonic.
Transducer, Ultrasonic,           HGL.............               0         6        0        0        0        6
 Obstetric.
Uterine Electromyographic         OSP.............               1         1        1        0        0        3
 Monitor.
Tonometer, Ac-Powered...........  HKX.............               0         0        0        0        1        1
Tonometer, Manual...............  HKY.............               3         4        0        1        0        8
Automated Digital Image Manual    OEO.............               1         0        0        0        0        1
 Interpretation Microscope.
System, X-Ray, Tomographic......  IZF.............              31         1        1        1        1       35
Analyzer, Medical Image.........  MYN.............               1         0        0        0        0        1
C-Arm Fluoroscopic X-Ray System.  RCC.............               0         0        0        1       72       73
                                 -------------------------------------------------------------------------------
    Total.......................  ................             322        71       22       23      101      539
----------------------------------------------------------------------------------------------------------------

    An additional 32 devices had from 1 to 32 reports in MAUDE after 
the PHE began and anywhere from 1 to 78 reports in MAUDE from November 
1, 2010 to the start of the PHE. These devices are shown in Table 4.1 
below.

                        Table 4.1--Review Devices with MAUDE Reports Before and After PHE
----------------------------------------------------------------------------------------------------------------
                                                                                                   MAUDE events
                                                                      Section in   MAUDE events     Post-PHE to
       Device description           Device  class    Product  code      21 CFR      November 1,    November 30,
                                                                                    2010 to PHE        2020
----------------------------------------------------------------------------------------------------------------
Vinyl Patient Examination Glove.  I...............  LYZ............     880.6250              40               1
Mechanical Ventilator...........  II..............  ONZ............     868.5895               2               1
Cannula, Arterial,                II..............  NCP............     870.4210               6               1
 Cardiopulmonary Bypass (Cpb),
 Embolism Protection.
Dual Lumen Ecmo Cannula.........  II..............  PZS............     870.4100               2               4
Respirator, N95, For Use By The   II..............  NZJ............     880.6260               1               1
 General Public In Public Health
 Medical Emergencies.
Sterilizer Automated Loading      II..............  PEC............     880.6880               8               1
 System.
Infusion Safety Management        II..............  PHC............     880.5725               6               1
 Software.
Gown, Isolation, Surgical.......  II..............  FYC............     878.4040              12               1
Non-Normalizing Quantitative      II..............  OLT............     882.1400              12               1
 Electroencephalograph Software.
Monitor, Ultrasonic, Fetal......  II..............  KNG............     884.2660              16               2
Whole Slide Imaging System......  II..............  PSY............     864.3700               2               1
Oxygenator, Long Term Support     II..............  BZG............     868.1840              10               1
 Greater Than 6 Hours.
Transmitters And Receivers,       II..............  BZQ............     868.2375              38               8
 Electrocardiograph, Telephone.

[[Page 4095]]

 
Extracorporeal System For Long-   II..............  NFB............     868.5905              24               1
 Term Respiratory/
 Cardiopulmonary Failure.
Catheter, Percutaneous,           II..............  NHJ............     868.5905              18               2
 Intraspinal, Short Term.
Implanted Subcutaneous            II..............  NHK............     868.5905              78               1
 Securement Catheter.
Subcutaneous Implanted Apheresis  II..............  QAV............     868.5454               0               1
 Port.
Non-Coring (Huber) Needle.......  II..............  BYS............     870.4100               0               1
Administrations Sets With         II..............  DXH............     870.2920              18               5
 Neuraxial Connectors.
Port & Catheter, Implanted,       II..............  QJZ............     870.4100               0              12
 Subcutaneous, Intraventricular.
Hood, Surgical..................  II..............  MAJ............     868.5120              17               1
N95 Respirator With               II..............  OKC............     880.5970              16               1
 Antimicrobial/Antiviral Agent.
Reduced- Montage Standard         II..............  PTD............     880.5965              40              32
 Electroencephalograph.
Monitor, Uterine Contraction,     II..............  PTI............     880.5570              36              10
 External (For Use In Clinic).
Coil, Magnetic Resonance,         II..............  PWH............     880.5440               0               5
 Specialty.
Solid State Fluoroscopic X-Ray    II..............  LKG............     882.5550              20               1
 Imager.
Oxygenator, Long Term Support     II..............  FXY............     878.4040              20               1
 Greater Than 6 Hours.
Transmitters And Receivers,       II..............  ONT............     878.4040               0               1
 Electrocardiograph, Telephone.
Extracorporeal System For Long-   II..............  OMC............     882.1400               0               1
 Term Respiratory/
 Cardiopulmonary Failure.
Catheter, Percutaneous,           II..............  HFM............     884.2720              13               1
 Intraspinal, Short Term.
Implanted Subcutaneous            II..............  MOS............     892.1000              72               1
 Securement Catheter.
Subcutaneous Implanted Apheresis  II..............  QHY............     892.1650               0               1
 Port.
----------------------------------------------------------------------------------------------------------------

    Table 4.2 presents the devices in Table 4.1 broken down by type of 
MAUDE. Of the 630 MAUDE reports analyzed, the majority (383 or 60.7%) 
involved product malfunctions with a limited number connected to death 
(24 or 3.8%).

                                                 Table 4.2--Review Devices in Table 4.1 by MAUDE Report
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                    MAUDE Reports
           Device descriptions                  Device class             Product code      -------------------------------------------------------------
                                                                                              Malfunction     Death    Injury   Other      NA     Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vinyl Patient Examination Glove.........  I......................  LYZ....................              20         0       19        1        1       41
Mechanical Ventilator...................  II.....................  ONZ....................               1         1        1        0        0        3
Cannula, Arterial, Cardiopulmonary        II.....................  NCP....................               2         0        5        0        0        7
 Bypass (Cpb), Embolism Protection.
Dual Lumen Ecmo Cannula.................  II.....................  PZS....................               1         1        4        0        0        6
Respirator, N95, For Use By The General   II.....................  NZJ....................               1         0        1        0        0        2
 Public In Public Health Medical
 Emergencies.
Sterilizer Automated Loading System.....  II.....................  PEC....................               7         0        2        0        0        9
Infusion Safety Management Software.....  II.....................  PHC....................               7         0        0        0        0        7
Gown, Isolation, Surgical...............  II.....................  FYC....................              12         0        1        0        0       13
Non-Normalizing Quantitative              II.....................  OLT....................              11         2        0        0        0       13
 Electroencephalograph Software.
Monitor, Ultrasonic, Fetal..............  II.....................  KNG....................               2         1       15        0        0       18
Whole Slide Imaging System..............  II.....................  PSY....................               2         0        1        0        0        3
Oxygenator, Long Term Support Greater     II.....................  BZG....................               7         0        2        1        1       11
 Than 6 Hours.
Transmitters And Receivers,               II.....................  BZQ....................              38         5        3        0        0       46
 Electrocardiograph, Telephone.
Extracorporeal System For Long-Term       II.....................  NFB....................              11         4        9        1        0       25
 Respiratory/Cardiopulmonary Failure.
Catheter, Percutaneous, Intraspinal,      II.....................  NHJ....................              10         1        9        0        0       20
 Short Term.
Implanted Subcutaneous Securement         II.....................  NHK....................              68         4        6        0        1       79
 Catheter.
Subcutaneous Implanted Apheresis Port...  II.....................  QAV....................               1         0        0        0        0        1
Non-Coring (Huber) Needle...............  II.....................  BYS....................               1         0        0        0        0        1
Administrations Sets With Neuraxial       II.....................  DXH....................               9         1        9        0        4       23
 Connectors.
Port & Catheter, Implanted,               II.....................  QJZ....................               9         1        2        0        0       12
 Subcutaneous, Intraventricular.
Hood, Surgical..........................  II.....................  MAJ....................              12         0        6        0        0       18
N95 Respirator With Antimicrobial/        II.....................  OKC....................              12         0        3        1        1       17
 Antiviral Agent.
Reduced- Montage Standard                 II.....................  PTD....................              52         1       19        0        0       72
 Electroencephalograph.
Monitor, Uterine Contraction, External    II.....................  PTI....................              22         0       24        0        0       46
 (For Use In Clinic).
Coil, Magnetic Resonance, Specialty.....  II.....................  PWH....................               5         0        0        0        0        5

[[Page 4096]]

 
Solid State Fluoroscopic X-Ray Imager...  II.....................  LKG....................              16         1        4        0        0       21
Oxygenator, Long Term Support Greater     II.....................  FXY....................              19         0        2        0        0       21
 Than 6 Hours.
Transmitters And Receivers,               II.....................  ONT....................               0         0        1        0        0        1
 Electrocardiograph, Telephone.
Extracorporeal System For Long-Term       II.....................  OMC....................               1         0        0        0        0        1
 Respiratory/Cardiopulmonary Failure.
Catheter, Percutaneous, Intraspinal,      II.....................  HFM....................              10         1        3        0        0       14
 Short Term.
Implanted Subcutaneous Securement         II.....................  MOS....................              13         0       52        7        1       73
 Catheter.
Subcutaneous Implanted Apheresis Port...  II.....................  QHY....................               1         0        0        0        0        1
                                                                                           -------------------------------------------------------------
                                                                   Total..................             383        24      203       11        9      630
--------------------------------------------------------------------------------------------------------------------------------------------------------

III. Exemption from 510(k) Premarket Notification Requirement

A. Class I Devices

    Section 510(l)(2)(A)-(B) of the FD&C Act, 21 U.S.C. 360(l)(2)(A)-
(B), provides that ``the Secretary shall identify through publication 
in the Federal Register, any type of class I device that the Secretary 
determines no longer requires a report under subsection (k) to provide 
reasonable assurance of safety and effectiveness'' and that ``[u]pon 
such publication--each type of class I device so identified shall be 
exempt from the requirement for a report under subsection (k); and the 
classification regulation applicable to each such type of device shall 
be deemed amended to incorporate such exemption.''
    In view of the complete lack of or de minimis number of adverse 
events in MAUDE following FDA's waiver of the premarket notification 
requirement for the class I devices listed in Tables 2, 3.1, and 4.1, 
the Department has concluded that the premarket notification 
requirement is no longer required to provide reasonable assurance of 
the safety and efficacy of those devices. As such, as of this Notice, 
the 7 class I devices listed in Table 5 below shall be exempt from the 
510(k) premarket notification requirement.

  Table 5--Class I Devices Immediately Exempt from 510(k) Notification
                               Requirement
------------------------------------------------------------------------
                                                              Section in
      Device description        Device class   Product code     21 CFR
------------------------------------------------------------------------
Powder-Free Polychloroprene    I............  OPC..........     880.6250
 Patient Examination Glove.
Patient Examination Glove,     I............  LZC..........     880.6250
 Specialty.
Radiation Attenuating Medical  I............  OPH..........     880.6250
 Glove.
Powder-Free Non-Natural        I............  OPA..........     878.4460
 Rubber Latex Surgeon''s
 Gloves.
Powder-Free Guayle Rubber      I............  OIG..........     880.6250
 Examination Glove.
Latex Patient Examination      I............  LYY..........     880.6250
 Glove.
Vinyl Patient Examination      I............  LYZ..........     880.6250
 Glove.
------------------------------------------------------------------------

B. Class II Devices

    Section 510(m)(2) of the FD&C Act, 21 U.S.C. 360(m)(2), provides 
that, after a 60-calendar-day-notice comment period, ``the Secretary 
may exempt a class II device from the requirement to submit a report 
under subsection (k) . . . if the Secretary determines that such report 
is not necessary to assure the safety and effectiveness of the 
device.'' Within 120 days of publication, ``the Secretary shall publish 
an order in the Federal Register that sets forth the final 
determination of the Secretary regarding the exemption of the device 
that was the subject of the notice.'' Given the lack of any adverse 
event reports in MAUDE for class II and the unclassified medical 
devices listed in Table 2, and the lack of non-death-related adverse 
event reports for class II devices in Tables 3.3 and 4.2, the 
Department has determined that 510(k) premarket notification for the 84 
class II devices and the unclassified device listed in Table 6 below is 
no longer necessary to assure the safety and effectiveness of those 
devices.

 Table 6--Class II Devices and Unclassified Devices Proposed Exempt from
                           510(k) Requirement
------------------------------------------------------------------------
                                                              Section in
      Device description        Device class   Product code     21 CFR
------------------------------------------------------------------------
Ventilator, Continuous,        II...........  NQY..........     868.5895
 Minimal Ventilatory Support,
 Home Use.
Airway Monitoring System.....  II...........  OQU..........     868.5730
Impedance Measuring Device     II...........  PNV..........     868.1840
 Utilizing Oscillation
 Techniques.
Gauge, Pressure, Coronary,     II...........  DXS..........     870.4310
 Cardiopulmonary Bypass.
Valve, Pressure Relief,        II...........  MNJ..........     870.4400
 Cardiopulmonary Bypass.
Oximeter, Tissue Saturation,   II...........  NMD..........     870.2700
 Reprocessed.
Multivariate Vital Signs       II...........  PLB..........     870.2300
 Index.
Electrocardiograph Software    II...........  QDA..........     870.2345
 For Over-The-Counter Use.
Sterilizer, Dry Heat.........  II...........  KMH..........     880.6870
Check Valve, Retrograde Flow   II...........  MJF..........     880.5440
 (In-Line).

[[Page 4097]]

 
Intravascular Administration   II...........  OKL..........     880.5445
 Set, Automated Air Removal
 System.
Neuraxial Administration Set-- II...........  PYR..........     880.5440
 Intrathecal Delivery.
High Level Disinfection        II...........  PSW..........     892.1570
 Reprocessing Instrument For
 Ultrasonic Transducers,
 Liquid.
Pediatric/Child Facemask.....  II...........  OXZ..........     878.4040
Normalizing Quantitative       II...........  OLU..........     882.1400
 Electroencephalograph
 Software.
Computerized Cognitive         II...........  PKQ..........     882.1470
 Assessment Aid.
Physiological Signal Based     II...........  POS..........     882.1580
 Seizure Monitoring System.
Computerized Behavioral        II...........  PWE..........     882.5801
 Therapy Device For
 Psychiatric Disorders.
Monitor, Phonocardiographic,   II...........  HFP..........     884.2640
 Fetal.
Monitor, Cardiac, Fetal......  II...........  KXN..........     884.2600
Digital Pathology Display....  II...........  PZZ..........     864.3700
Digital Pathology Image        II...........  QKQ..........     864.3700
 Viewing And Management
 Software.
System, Imaging, Holography,   II...........  NCS..........     892.1550
 Acoustic.
Lung Computed Tomography       II...........  OEB..........     892.2050
 System, Computer-Aided
 Detection.
Chest X-Ray Computer Aided     II...........  OMJ..........     892.2050
 Detection.
Computer-Assisted Diagnostic   II...........  POK..........     892.2060
 Software For Lesions
 Suspicious For Cancer.
Radiological Computer-         II...........  QAS..........     892.2080
 Assisted Triage And
 Notification Software.
Radiological Computer          II...........  QBS..........     892.2090
 Assisted Detection/Diagnosis
 Software For Fracture.
Radiological Computer          II...........  QDQ..........     892.2090
 Assisted Detection/Diagnosis
 Software For Lesions
 Suspicious For Cancer.
Radiological Computer-         II...........  QFM..........     892.2080
 Assisted Prioritization
 Software For Lesions.
X-Ray Angiographic Imaging     II...........  QHA..........     892.1600
 Based Coronary Vascular
 Simulation Software Device.
Automated Radiological Image   II...........  QIH..........     892.2050
 Processing Software.
Image Acquisition And/Or       II...........  QJU..........     892.2100
 Optimization Guided By
 Artificial Intelligence.
Apparatus, Vestibular          Unclassified.  LXV..........          N/A
 Analysis.
Meter, Peak Flow, Spirometry.  II...........  BZH..........     868.1860
Oximeter, Reprocessed........  II...........  NLF..........     870.2700
Stethoscope, Electronic......  II...........  DQD..........     870.1875
Defoamer, Cardiopulmonary      II...........  DTP..........     870.4230
 Bypass.
Filter, Blood, Cardiotomy      II...........  JOD..........     870.4270
 Suction Line,
 Cardiopulmonary Bypass.
Detector, Bubble,              II...........  KRL..........     870.4205
 Cardiopulmonary Bypass.
Cpb Check Valve, Retrograde    II...........  MJJ..........     870.4400
 Flow, In-Line.
Sterilizer, Ethylene-Oxide     II...........  FLF..........     880.6860
 Gas.
Cabinet, Ethylene-Oxide Gas    II...........  FLI..........     880.6100
 Aerator.
Purifier, Air, Ultraviolet,    II...........  FRA..........     880.6500
 Medical.
Cleaner, Air, Medical          II...........  FRF..........     880.5045
 Recirculating.
Controller, Infusion,          II...........  LDR..........     880.5725
 Intravascular, Electronic.
Cleaners, Medical Devices....  II...........  MDZ..........     880.6992
Percutaneous, Implanted, Long- II...........  OMF..........     880.5970
 Term Intravascular Catheter
 Accessory For Catheter
 Position.
N95 Respirator With            II...........  ORW..........     880.6260
 Antimicrobial/Antiviral
 Agent For Use By The General
 Public In Public Health
 Medical Emergencies.
Two Or More Sterilant          II...........  PJJ..........     880.6860
 Sterilizer.
High Level Disinfection        II...........  OUJ..........     892.1570
 Reprocessing Instrument For
 Ultrasonic Transducers, Mist.
Surgical Mask With             II...........  OUK..........     878.4040
 Antimicrobial/Antiviral
 Agent.
Cerebral Oximeter............  II...........  QEM..........     870.2700
Device, Sleep Assessment.....  II...........  LEL..........     882.5050
Standard Polysomnograph With   II...........  OLV..........     882.1400
 Electroencephalograph.
Source Localization Software   II...........  OLX..........     882.1400
 For Electroencephalograph Or
 Magnetoencephalograph.
Automatic Event Detection      II...........  OLZ..........     882.1400
 Software For Polysomnograph
 With Electroencephalograph.
Amplitude-Integrated           II...........  OMA..........     882.1400
 Electroencephalograph.
Automatic Event Detection      II...........  OMB..........     882.1400
 Software For Full-Montage
 Electroencephalograph.
Burst Suppression Detection    II...........  ORT..........     882.1400
 Software For
 Electroencephalograph.
Transducer, Ultrasonic,        II...........  HGL..........     884.2960
 Obstetric.
Tonometer, Ac-Powered........  II...........  HKX..........     886.1930
Tonometer, Manual............  II...........  HKY..........     886.1930
Automated Digital Image        II...........  OEO..........     864.1860
 Manual Interpretation
 Microscope.
Analyzer, Medical Image......  II...........  MYN..........     892.2070
C-Arm Fluoroscopic X-Ray       II...........  RCC..........     892.1650
 System.
Cannula, Arterial,             II...........  NCP..........     870.4210
 Cardiopulmonary Bypass
 (Cpb), Embolism Protection.
Respirator, N95, For Use By    II...........  NZJ..........     880.6260
 The General Public In Public
 Health Medical Emergencies.
Sterilizer Automated Loading   II...........  PEC..........     880.6880
 System.
Infusion Safety Management     II...........  PHC..........     880.5725
 Software.
Gown, Isolation, Surgical....  II...........  FYC..........     878.4040
Whole Slide Imaging System...  II...........  PSY..........     864.3700
Oxygenator, Long Term Support  II...........  BZG..........     868.1840
 Greater Than 6 Hours.
Subcutaneous Implanted         II...........  QAV..........     868.5454
 Apheresis Port.
Non-Coring (Huber) Needle....  II...........  BYS..........     870.4100
Hood, Surgical...............  II...........  MAJ..........     868.5120
N95 Respirator With            II...........  OKC..........     880.5970
 Antimicrobial/Antiviral
 Agent.
Monitor, Uterine Contraction,  II...........  PTI..........     880.5570
 External (For Use In Clinic).
Coil, Magnetic Resonance,      II...........  PWH..........     880.5440
 Specialty.

[[Page 4098]]

 
Oxygenator, Long Term Support  II...........  FXY..........     878.4040
 Greater Than 6 Hours.
Transmitters And Receivers,    II...........  ONT..........     878.4040
 Electrocardiograph,
 Telephone.
Extracorporeal System For      II...........  OMC..........     882.1400
 Long-Term Respiratory/
 Cardiopulmonary Failure.
Implanted Subcutaneous         II...........  MOS..........     892.1000
 Securement Catheter.
Subcutaneous Implanted         II...........  QHY..........     892.1650
 Apheresis Port.
------------------------------------------------------------------------

C. Impact of Exemptions on Patient Access to Medical Devices

    With this Notice, the Department is immediately exempting 7 devices 
from the premarket notification requirement, and proposes to exempt an 
additional 84 devices from the requirement after public comment is 
closed. As noted above in Part I.A, estimates on the cost of preparing 
a 510(k) submission range from $100,000 to $4 million. The exemptions 
provided for and proposed under this Notice for these 91 device classes 
could eliminate anywhere from $9.1 to $364 million in startup costs if 
there were one new entrant into each device market. Savings could 
further accrue based on each new market entrant. Instead of being costs 
passed along to patients and taxpayers, these savings could be invested 
in other areas such as research and development and manufacturing.
    At the same time, should these waivers go into effect as proposed, 
patients stand to gain more immediate access to new products that would 
otherwise be required to obtain a 510(k) clearance prior to marketing.
    The exemptions provided for in this Notice also conserve FDA's 
scarce review resources. The COVID-19 PHE stretched FDA's review 
capacity. Under this Notice, FDA's review resources can be redeployed 
to review other innovative technology, to include devices designed to 
mitigate the impact of COVID-19.

IV. Request for Information, Data, and Further Study

    HHS' review in this Notice warrants expansion and further study. 
FDA's medical device Product Code database contains 6,651 unique codes 
(to include those discussed in this Notice). Of those unique codes, 157 
are for class I devices that require 510(k) clearance, and 2,662 are 
for class II devices that require 510(k) clearance. Applying the 
$100,000 to $4 million in estimated costs for 510(k) preparation and 
submission to these 2,819 devices yields approximately $281.9 million 
to $11.276 billion in startup costs, assuming one new market entrant in 
each of the 2,819 device classes. Further, again assuming a 90-day 
review period and one new device entrant in each of the 2,819 device 
classes that require 510(k) notification, FDA's current approach 
creates 253,710 review days or 695.1 review years between Americans and 
new devices. The question of whether the 510(k) notice is justified in 
view of safety and efficacy concerns merits comprehensive analysis for 
the benefit of Americans. The Department seeks public comment, 
research, and analysis on whether other devices should be exempt from 
the premarket notification requirement.
    At a more detailed level, the Department observed internal 
inconsistencies in FDA's regulation of some device classes that merit 
discussion. Manual stethoscopes are exempt from the premarket 
notification requirement. 21 CFR 870.1875(a)(2). Electronic 
stethoscopes are also exempt, but only if the device ``is a lung sound 
monitor.'' 21 CFR 870.1875(b)(2). Similarly, FDA exempts ``clinical 
mercury thermometer . . . device[s] used to measure oral, rectal, or 
axillary (armpit) body temperature using the thermal expansion of 
mercury'' from the 510(k) premarket notification requirement. 21 CFR 
880.2920. By contrast, clinical electronic thermometers which never 
enter into any body orifice require 510(k) premarket notification. 21 
CFR 880.2910. These apparent inconsistencies merit scientific scrutiny. 
To that end, the Department seeks public comment as to whether other 
inconsistencies in the medical device regulatory framework exist.

    Dated: January 8, 2021.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-00787 Filed 1-14-21; 8:45 am]
BILLING CODE 4150-26-P


