[Federal Register Volume 84, Number 170 (Tuesday, September 3, 2019)]
[Notices]
[Pages 46023-46024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18929]
[[Page 46023]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-2837]
Testing and Labeling Medical Devices for Safety in the Magnetic
Resonance Environment; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice of availability that
appeared in the Federal Register of August 2, 2019. In the notice of
availability, FDA requested comments on draft guidance for industry and
FDA staff entitled ``Testing and Labeling Medical Devices for Safety in
the Magnetic Resonance (MR) Environment.'' The Agency is taking this
action in response to a request for an extension to allow interested
persons additional time to submit comments.
DATES: FDA is extending the comment period on the document published
August 2, 2019 (84 FR 37886). Submit either electronic or written
comments on the draft guidance by October 31, 2019, to ensure that the
Agency considers your comment on this draft guidance before it begins
work on the final version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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-2019-D-2837 for ``Testing and Labeling Medical Devices for Safety
in the Magnetic Resonance (MR) Environment; Draft Guidance for Industry
and Food and Drug Administration Staff.'' Received comments 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Testing and Labeling Medical Devices for Safety in the Magnetic
Resonance (MR) Environment'' to the Office of Policy, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT: Terry Woods, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 62, Rm. 2116, Silver Spring, MD 20993-0002, 301-796-2503.
[[Page 46024]]
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 2, 2019, FDA published a notice
of availability with a 60-day comment period to request comments on the
draft guidance for industry and FDA staff entitled ``Testing and
Labeling Medical Devices for Safety in the Magnetic Resonance (MR)
Environment.''
The Agency has received a request for a 30-day extension of the
comment period. The request conveyed concern that the current 60-day
comment period does not allow sufficient time to develop a meaningful
or thoughtful response.
FDA has considered the request and is extending the comment period
for the notice of availability for 30 days, until October 31, 2019. The
Agency believes that a 30-day extension allows adequate time for
interested persons to submit comments without significantly delaying
guidance on these important issues.
II. Significance of Guidance
FDA is issuing this draft guidance consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on this topic. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov. Persons unable to download an
electronic copy of ``Testing and Labeling Medical Devices for Safety in
the Magnetic Resonance (MR) Environment'' may send an email request to
[email protected] to receive an electronic copy of the
document. Please use the document number 1500059 to identify the
guidance you are requesting.
Dated: August 28, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18929 Filed 8-30-19; 8:45 am]
BILLING CODE 4164-01-P