[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