[Federal Register Volume 85, Number 26 (Friday, February 7, 2020)]
[Notices]
[Pages 7311-7313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02481]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0825]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Premarket Approval of 
Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March 
9, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0231. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Premarket Approval of Medical Devices

OMB Control Number 0910-0231--Extension

    Under section 515 of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 360e) all devices placed into class III by FDA are 
subject to premarket approval application (PMA) requirements. PMA is 
the process of scientific and regulatory review to ensure the safety 
and effectiveness of class III devices. An approved PMA is, in effect, 
a private license granted to the applicant for marketing a particular 
medical device. A class III device that fails to meet PMA requirements 
is considered to be adulterated under section 501(f) of the FD&C Act 
(21 U.S.C. 351(f)) and cannot be marketed. PMA requirements apply 
differently to preamendments devices, postamendments devices, and 
transitional class III devices.
    Manufacturers of class III preamendments devices (devices that were 
in commercial distribution before May 28, 1976) are not required to 
submit a PMA until 30 months after the issuance of a final 
classification regulation or until 90 days after the publication of a 
final regulation requiring the submission of a PMA, whichever period is 
later. FDA may allow more than 90 days after issuance of a final rule 
for submission of a PMA.
    A postamendments device is one that was first distributed 
commercially on or after May 28, 1976. Postamendments devices 
determined by FDA to be substantially equivalent to preamendments class 
III devices are subject to the same requirements as the preamendments 
devices. FDA determines substantial equivalence after reviewing an 
applicant's premarket notification submitted in accordance with section 
510(k) of the FD&C Act. Postamendments devices determined by FDA to be 
not substantially equivalent to either preamendments devices or 
postamendments devices classified into class I or II are ``new'' 
devices and fall automatically into class III. Before such devices can 
be marketed, they must have an approved PMA or must be reclassified 
into class I or class II.
    The Food and Drug Administration Modernization Act of 1997 (FDAMA) 
(Pub. L. 105-115) amended the FD&C Act by streamlining the process of 
bringing safe and effective drugs, medical devices, and other therapies 
to the U.S. market. FDAMA added section 515(d)(6) to the FD&C Act, 
which provided that PMA supplements were required for all device 
changes that affect safety and effectiveness unless such changes are 
modifications to manufacturing procedures or method of manufacture. 
That type of manufacturing change requires a 30-day notice, or where 
FDA finds such notice inadequate, a 135-day PMA supplement.
    The implementing regulations, contained in 21 CFR part 814, further 
specify the contents of a PMA for a medical device and the criteria FDA 
will employ in approving, denying, or withdrawing approval of a PMA and 
supplements to PMAs. The regulations' purpose is to establish an 
efficient and thorough procedure for FDA's review of PMAs and 
supplements to PMAs for class III medical devices. The regulations 
facilitate the approval of PMAs and supplements to PMAs for devices 
that have been shown to be reasonably safe and effective and otherwise 
meet the statutory criteria for approval. The regulations also allow 
for the denial of PMAs and supplements to PMAs for devices that have 
not been shown to be reasonably safe and effective and that do not 
otherwise meet the statutory criteria for approval.
    The burden estimate is based on the annual rate of receipt of PMA 
submissions for fiscal years (FYs) 2016 through 2018 and our 
expectation of submissions to come in the next few years. The burden 
data for PMAs is based on data provided by applicants by device type 
and cost element in an earlier study.

Reporting Burden

    Section 814.15(b)--Research Conducted Outside the United States. 
FDA will accept information on a clinical investigation conducted 
outside the United States (OUS) to support a PMA if the investigation 
is well-designed and well-conducted and certain other conditions are 
met, including that the investigation was conducted in accordance with 
good clinical practice (GCP) as specified in 21 CFR 812.28. If the OUS 
clinical investigation did not conform to GCP, then the PMA submission 
should include a waiver request or a statement explaining the reason 
for not conducting the investigation in accordance with GCP and a 
description of steps taken to ensure that the data and results are 
credible and accurate and that the rights, safety, and well-being of 
subjects have been adequately protected. Based on the number of PMAs 
received that contained studies from overseas, FDA estimates that the 
burden estimate necessary to meet this requirement is 50 hours.
    Section 814.20--Application. Specifies the information required in 
a PMA and update reports such as the applicant's name and address, a 
description of the device, its labeling, its indications for use, and 
summary of clinical and non-clinical studies. Included in this 
requirement is the conduct of laboratory and clinical trials, as well 
as the analysis, review, and physical preparation of the PMA 
application. FDA estimates that 38 applicants, including hospital 
remanufacturers of single-use devices, will be affected by these 
requirements, which are based on the actual average of FDA receipt of 
new PMA applications in FYs 2016 through 2018.
    Additionally, the ``Human Subject Protection; Acceptance of Data 
from

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Clinical Investigations for Medical Devices'' final rule (83 FR 7366; 
February 21, 2018) amended this section to address requirements for a 
PMA supported by data from clinical investigations conducted outside 
the United States. The applicant will be required to submit the 
information as described in Sec.  814.20(b)(6)(ii)(C). We estimate this 
will take 30 minutes per respondent. We estimate that 10 respondents 
annually will submit such information.
    The collections in OMB control number 0910-0741, ``Human Subject 
Protection; Acceptance of Data from Clinical Studies for Medical 
Devices,'' were submitted to OMB as a new information collection 
request with the expectation that the currently approved requirements 
will be amended. As noted in the Supporting Statement for OMB control 
number 0910-0741, we are amending OMB control number 0910-0231 to 
reflect the information collections associated with the rulemaking 
under Sec.  814.20(b)(6)(ii)(C).
    Section 814.37(a) through (c) and (e)--PMA Amendments and 
Resubmitted PMAs. As part of the review process, FDA often requests the 
PMA applicant to submit additional information regarding the device 
necessary for FDA to file the PMA or to complete its review and make a 
final decision. The PMA applicant may, on their own initiative, submit 
additional information to FDA during the review process. These 
amendments contain information ranging from additional test results and 
reanalysis of the original data set to revised device labeling. Almost 
all PMAs received by the Agency have amendments submitted during the 
review process.
    Section 814.39(a)--PMA Supplements. This information collection 
includes the requirements for the range of PMA supplements (panel 
track, 180-day fee-based, 180-day non-fee-based, and real-time 
supplements).
    Section 814.39(d)--Special PMA Supplements--Changes Being Affected. 
This type of supplement is intended to enhance the safety of the device 
or the safe use of the device. The number of PMA supplements received 
that fit this category averaged 75 per year based on the numbers 
received from FYs 2016 through 2018.
    Section 814.39(f)--30-Day Notice. Under section 515(d) of the FD&C 
Act, modifications to manufacturing procedures or methods of 
manufacture that affect the safety and effectiveness of a device 
subject to an approved PMA do not require submission of a PMA 
supplement under paragraph (a) of that section and are eligible to be 
the subject of a 30-day notice. A 30-day notice shall describe in 
detail the change, summarize the data or information supporting the 
change, and state that the change has been made in accordance with the 
requirements of part 820 (21 CFR part 820). The applicant may 
distribute the device 30 days after the date on which FDA receives the 
30-day notice, unless FDA notifies the applicant within 30 days from 
receipt of the notice that it is not adequate.
    Section 814.82(a)(9)--Postapproval Requirements. Postapproval 
requirements concern approved PMAs that were not reclassified and 
require a periodic report. After approval, all PMAs require a 
submission of an annual report. A majority of the submitted PMAs 
require associated postapproval studies, i.e., followup of patients 
used in clinical trials to support the PMA or additional preclinical 
information that is labor-intensive to compile and complete; the 
remaining PMAs require minimal information.
    Section 814.84(b)--Periodic Reports. Postapproval requirements 
described in Sec.  814.82(a)(7) require submission of an annual report 
for each approved PMA. FDA estimates that respondents will average 
about 10 hours in preparing their reports to meet this requirement. 
This estimate is based on FDA's experience and consultation with 
industry.
    The Breakthrough Devices Program--The Breakthrough Devices Program 
supersedes the Expedited Access Pathway and Priority Review for medical 
devices. The guidance document ``Breakthrough Devices Program'' 
implements section 515B of the FD&C Act (21 U.S.C. 360e-3), as created 
by section 3051 of the 21st Century Cures Act (Pub. L. 114-255) and 
amended by section 901 of the FDA Reauthorization Act of 2017 (Pub. L. 
115-52). The Breakthrough Devices Program is a voluntary program for 
certain medical devices and device-led combination products that 
provide for more effective treatment or diagnosis of life-threatening 
or irreversibly debilitating diseases or conditions. The program is 
intended to help patients have more timely access to these medical 
devices by expediting their development, assessment, and review, while 
preserving the statutory standards for premarket approval, 510(k) 
clearance, and De Novo marketing authorization, consistent with the 
Agency's mission to protect and promote public health.
    Section 520(g)(7) of the FD&C Act (21 U.S.C. 360j(g)(7))--Agreement 
Meeting. Applicants planning to submit a PMA may submit a written 
request to reach agreement with FDA on the key parameters of the 
investigational plan.
    Section 513(a)(3)(D) of the FD&C Act (21 U.S.C. 360c(a)(3)(D))--
Determination Meeting. Applicants planning to submit a PMA may submit a 
written request to FDA for a meeting to determine the type of 
information (valid scientific evidence) necessary to support the 
effectiveness of their device.
    Section 515(c)(3) of the FD&C Act--Panel of Experts. An original 
PMA or panel track PMA supplement is taken to an advisory panel of 
experts unless FDA determines that the information in the application 
substantially duplicates information that has previously been reviewed 
by the panel.
    Section 515(d)(3) of the FD&C Act--Day 100 Meeting. FDA must, upon 
the written request of the applicant, meet with that party within 100 
days of receipt of the filed PMA application to discuss the review 
status of the application. With the concurrence of the applicant, a 
different schedule may be established. Prior to this meeting, FDA must 
inform the applicant in writing of any identified deficiencies and what 
information is required to correct those deficiencies. FDA must also 
promptly notify the applicant if FDA identifies additional deficiencies 
or of any additional information required to complete Agency review.

Recordkeeping

    Section 814.82(a)(5) and (6)--Maintenance of Records. The 
recordkeeping burden under this section requires the maintenance of 
records used to trace patients, and the organization and indexing of 
records into identifiable files to ensure the device's continued safety 
and effectiveness. These records are required of all applicants who 
have an approved PMA.
    PMAs have been required since 1976, and there are 801 active PMAs 
that could be subject to these requirements, based on actual FDA data, 
and approximately 39 new PMAs are approved every year. The aggregate 
burden for the estimated 446 PMA holders of approved original PMAs for 
the next few years is estimated to be 7,582 hours.
    The applicant determines which records should be maintained during 
product development to document and/or substantiate the device's safety 
and effectiveness. Records required by the current good manufacturing 
practices for medical devices regulation (part 820) may be relevant to 
a PMA review and may be submitted as part of an application. In 
individual instances, records may be required as conditions of

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approval to ensure the device's continuing safety and effectiveness.
    In the Federal Register of October 24, 2019 (84 FR 57030), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                  Number of
 Activity/21 CFR or FD&C Act      Number of     responses per   Total annual     Average burden     Total hours
           section               respondents     respondent       responses       per response
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Research conducted outside                 25               1              25                  2              50
 the United States
 (814.15(b)).................
PMA application (814.20).....              46               1              46                668          30,728
Information on clinical                    10               1              10   0.5 (30 minutes)               5
 investigations conducted
 outside the United States
 (814.20(b)(6)(ii)(C)).......
PMA amendments and                      1,528               1           1,528                167         255,176
 resubmitted PMAs (814.37(a)-
 (c) and (e))................
PMA supplements (814.39(a))..             777               1             777                 60          46,620
Special PMA supplement--                   75               1              75                  6             450
 changes being affected
 (814.39(d)).................
30-day notice (814.39(f))....           1,722               1           1,722                 16          27,552
Postapproval requirements                 121               1             121                135          16,335
 (814.82(a)(9))..............
Periodic reports (814.84(b)).             764               1             764                 10           7,640
Agreement meeting (520(g)(7))               1               1               1                 50              50
Breakthrough Devices Program               11               1              11                 10             110
 (515(B) of the FD&C Act)....
Determination Meeting                       1               1               1                 50              50
 (513(1)(3)(D) of the FD&C
 Act)........................
Panel meeting (515(c)(3) of                 1               1               1                 30              30
 the FD&C Act)...............
Day 100 meeting (515(d)(3) of              14               1              14                 10             140
 the FD&C Act)...............
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ..............  ..............  .................         384,936
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                       Average burden
                      Activity/21 CFR section                           Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of records (814.82(a)(5) and (6))......................             446                1              446               17            7,582
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We made the following changes to the information collection:
     Added the burden estimate for ``Information on clinical 
investigations conducted outside the United States (Sec.  
814.20(b)(6)(ii)(C)),'' which is associated with the ``Human Subject 
Protection; Acceptance of Data from Clinical Investigations for Medical 
Devices'' final rule as described previously in this document.
     Revised the burden description and table to reflect that 
the Expedited Access Pathway and Priority Review have been superseded 
by the Breakthrough Devices Program.
     Updated our burden estimate with FYs 2016 through 2018 
data.
    These adjustments resulted in an overall increase of 34,782 hours 
to the estimated burden.

    Dated: January 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02481 Filed 2-6-20; 8:45 am]
 BILLING CODE 4164-01-P


