[Federal Register Volume 84, Number 179 (Monday, September 16, 2019)]
[Notices]
[Pages 48623-48625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19978]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-P-3347]
Medical Devices; Exemption From Premarket Notification: Class II;
Powered Wheeled Stretcher; 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 Agency) is announcing
that it has received a petition requesting exemption from the premarket
notification requirements for powered wheeled stretchers. These devices
are battery-powered tables with wheels that are intended for medical
purposes for use by patients who are unable to propel themselves
independently and who must maintain a prone or supine position for
prolonged periods because of skin ulcers or contractures (muscle
contractions). FDA is publishing this notice to obtain comments in
accordance with procedures established by the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
DATES: Submit either electronic or written comments by November 15,
2019.
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 November 15, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 15, 2019. 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:
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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-2019-P-3347 for ``Medical Devices; Exemption From Premarket
Notification: Powered Wheeled Stretcher.'' 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: Bryan Benesch, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993-0002, 301-796-5506.
SUPPLEMENTARY INFORMATION:
I. Statutory Background
FDA classifies devices into one of three regulatory classes: class
I, class II, or class III, based on the amount of regulation necessary
to provide a reasonable assurance of safety and effectiveness (see
section 513 of the FD&C Act (21 U.S.C. 360c)). 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 (Pub. L. 114-255) (Cures Act) 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, section 510(m)(2) of the
FD&C Act provides that, 1 calendar day after the date of publication of
the final list under paragraph (1)(B), 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 notice of its intent to exempt the
device, or the petition, and provide a 60-calendar 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 this
section within 180 days of receiving it, the petition shall be deemed
granted.
II. Criteria 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
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)
(available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf). As
discussed in that guidance document, FDA generally considers the
following factors to determine whether a report under section 510(k) 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
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still be subject to the general limitations on exemptions.
III. Proposed Class II Device Exemptions
FDA has received the following petition requesting an exemption
from premarket notification for a class II device: Stryker, 3800 East
Centre Ave., Portage, MI 49002, for powered wheeled stretcher,
classified under 21 CFR 890.3690. With this notice FDA is seeking
comments on the petition in accordance with section 510(m)(2) of the
FD&C Act.
IV. Paperwork Reduction Act of 1995
This notice refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120.
Dated: September 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19978 Filed 9-13-19; 8:45 am]
BILLING CODE 4164-01-P