[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Notices]
[Pages 51633-51635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24163]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1129]


Medical Devices; Exemptions From Premarket Notification: Class II 
Devices; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing its intent to exempt a list of class II devices from 
premarket notification requirements, subject to certain limitations. 
The Agency has determined that, based on established factors, these 
devices no longer require premarket notification to provide reasonable 
assurance of safety and effectiveness. FDA is publishing this notice to 
obtain comments regarding the proposed exemptions, in accordance with 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

DATES: Submit either electronic or written comments on the notice by 
January 8, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 8, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 8, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-1129 for ``Medical Devices; Exemptions from Premarket 
Notification: Class II Devices; Request for Comments.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Bryce Bennett, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, 301-348-1446, 
[email protected].

SUPPLEMENTARY INFORMATION :

I. Statutory Background

    Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the 
implementing regulations, 21 CFR part 807 subpart E, require persons 
who intend to market a new device to submit and obtain clearance of a 
premarket notification (510(k)) containing information that allows FDA 
to determine whether the new device is ``substantially equivalent'' 
within the meaning of section 513(i) of the FD&C Act to a legally 
marketed device that does not require premarket approval.
    The 21st Century Cures Act (Cures Act) (Pub. L. 114-255) was signed 
into law on December 13, 2016. Section 3054 of the Cures Act amended 
section 510(m) of the FD&C Act. As amended,

[[Page 51634]]

section 510(m)(1)(A) of the FD&C Act requires FDA to publish in the 
Federal Register a notice containing a list of each type of class II 
device that FDA determines no longer requires a report under section 
510(k) of the FD&C Act to provide reasonable assurance of safety and 
effectiveness. FDA is required to publish this notice within 90 days of 
the date of enactment of the Cures Act and at least once every 5 years 
thereafter, as FDA determines appropriate. Additionally, FDA must 
provide at least a 60-day comment period for any such notice required 
to be published under section 510(m)(1)(A) of the FD&C Act. FDA 
published this notice in the Federal Register of March 14, 2017 (82 FR 
13609). Under section 510(m)(1)(B) of the FD&C Act, FDA must publish in 
the Federal Register, within 210 days of enactment of the Cures Act, a 
list representing its final determination regarding the exemption of 
the devices that were contained in the list published under section 
510(m)(1)(A). FDA published that list in the Federal Register of July 
11, 2017 (82 FR 31976).
    As amended, section 510(m)(2) of the FD&C Act provides that, 1 day 
after the date of publication of the final list under section 
510(m)(1), FDA may exempt a class II device from the requirement to 
submit a report under section 510(k) of the FD&C Act upon its own 
initiative or a petition of an interested person, if FDA determines 
that a report under section 510(k) is not necessary to assure the 
safety and effectiveness of the device. To do so, FDA must publish in 
the Federal Register a notice of its intent to exempt the device, or of 
the petition, and provide a 60-day period for public comment. Within 
120 days after the issuance of this notice, FDA must publish an order 
in the Federal Register that sets forth its final determination 
regarding the exemption of the device that was the subject of the 
notice. If FDA fails to respond to a petition under section 510(m)(2) 
of the FD&C Act within 180 days of receiving it, the petition shall be 
deemed granted.

II. Factors FDA May Consider for Exemption

    There are a number of factors FDA may consider to determine whether 
a 510(k) is necessary to provide reasonable assurance of the safety and 
effectiveness of a class II device. These factors are discussed in the 
January 21, 1998, Federal Register notice (63 FR 3142) and subsequently 
in the guidance the Agency issued on February 19, 1998, entitled 
``Procedures for Class II Device Exemptions from Premarket 
Notification, Guidance for Industry and CDRH Staff'' (``Class II 510(k) 
Exemption Guidance'') (Ref. 1). Accordingly, FDA generally considers 
the following factors to determine whether premarket notification is 
necessary for class II devices: (1) The device does not have a 
significant history of false or misleading claims or of risks 
associated with inherent characteristics of the device; (2) 
characteristics of the device necessary for its safe and effective 
performance are well established; (3) changes in the device that could 
affect safety and effectiveness will either (a) be readily detectable 
by users by visual examination or other means such as routine testing, 
before causing harm, or (b) not materially increase the risk of injury, 
incorrect diagnosis, or ineffective treatment; and (4) any changes to 
the device would not be likely to result in a change in the device's 
classification. FDA may also consider that, even when exempting 
devices, these devices would still be subject to the limitations on 
exemptions.

III. Limitations on Exemptions

    FDA has determined that premarket notification is not necessary to 
assure the safety and effectiveness of the class II devices listed in 
table 1. This determination is based, in part, on the Agency's 
knowledge of the device, including past experience and relevant reports 
or studies on device performance (as appropriate), the applicability of 
general and special controls, and the Agency's ability to limit an 
exemption.

A. General Limitations of Exemptions

    FDA's proposal to grant an exemption from premarket notification 
for class II devices listed in table 1 applies only to those devices 
that have existing or reasonably foreseeable characteristics of 
commercially distributed devices within that generic type, or, in the 
case of in vitro diagnostic devices, for which a misdiagnosis, as a 
result of using the device, would not be associated with high morbidity 
or mortality. FDA proposes that a manufacturer of a listed device would 
still be required to submit a premarket notification to FDA before 
introducing a device or delivering it for introduction into commercial 
distribution when the device meets any of the conditions described in 
21 CFR 862.9 to 21 CFR 892.9.

B. Partial Limitations of Exemptions

    In addition to the general limitations, FDA may also partially 
limit an exemption from premarket notification requirements to specific 
devices within a listed device type when initial Agency assessment 
determines that the factors laid out in the Class II 510(k) Exemption 
Guidance (Ref. 1) do not weigh in favor of exemption for all devices in 
a particular group. In such situations where a partial exemption 
limitation has been identified, FDA has determined that premarket 
notification is necessary to provide a reasonable assurance of safety 
and effectiveness for these devices. In table 1, for example, FDA is 
listing the proposed exemption of the genetic health risk assessment 
system, but limits the exemption to such devices that have received a 
first-time FDA marketing authorization (e.g., 510(k) clearance) for the 
genetic health risk assessment system (a ``one-time FDA reviewed 
genetic health risk assessment system''). FDA believes that a one-time 
FDA review (e.g., premarket notification) of a genetic health risk 
assessment system is necessary to provide reasonable assurance of the 
safety and effectiveness of the device. FDA believes that a one-time 
FDA review of a genetic health risk assessment system is necessary to 
mitigate the risk of false negatives and false positives by ensuring 
that certain information be submitted to FDA to allow the Agency to 
assess the safety and effectiveness of the devices and the regulatory 
controls necessary to address those issues as well as to ensure the 
devices perform to acceptable standards.

IV. List of Class II Devices

    FDA is identifying the following list of class II devices that, if 
finalized, would no longer require premarket notification under section 
510(k) of the FD&C Act, subject to the general limitations to the 
exemptions found in Sec. Sec.  862.9 to 892.9:

                                            Table 1--Class II Devices
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                                                                                    Partial exemption limitation
         21 CFR section                    Device type             Product code            (if applicable)
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862.1840........................  Total 25-hydroxyvitamin D     PSL
                                   Mass Spectrometry Test
                                   System.

[[Page 51635]]

 
866.5950........................  Genetic Health Risk           PTA                 Exemption is limited to a
                                   Assessment System.                                genetic health risk
                                                                                     assessment system that has
                                                                                     received a first-time FDA
                                                                                     marketing authorization
                                                                                     (e.g., 510(k) clearance)
                                                                                     for the genetic health risk
                                                                                     assessment system (a ``one-
                                                                                     time FDA reviewed genetic
                                                                                     health risk assessment
                                                                                     system'').
876.1500........................  Endoscopic Maintenance        PUP
                                   System.
880.6710........................  Purifier, Water,              KMG
                                   Ultraviolet, Medical.
884.5960........................  Vibrator for Therapeutic      KXQ
                                   Use, Genital.
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V. Reference

    The following reference is on display in the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. FDA Guidance, ``Procedures for Class II Device Exemptions from 
Premarket Notification, Guidance for Industry and CDRH Staff,'' 
February 19, 1998, available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.

    Dated: October 31, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-24163 Filed 11-6-17; 8:45 am]
BILLING CODE 4164-01-P


