[Federal Register Volume 84, Number 197 (Thursday, October 10, 2019)]
[Notices]
[Pages 54609-54611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22194]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1775]
Coronary, Peripheral, and Neurovascular Guidewires--Performance
Tests and Recommended Labeling; Guidance for Industry and Food and Drug
Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Coronary, Peripheral,
and Neurovascular Guidewires--Performance Tests and Recommended
Labeling.'' This guidance provides recommendations for the information
and testing that should be included in premarket submissions for
guidewires intended for use in the coronary vasculature, peripheral
vasculature, and neurovasculature.
DATES: The announcement of the guidance is published in the Federal
Register on October 10, 2019.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
[[Page 54610]]
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-2018-D-1775 for ``Coronary, Peripheral, and Neurovascular
Guidewires--Performance Tests and Recommended Labeling.'' 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 guidance document entitled
``Coronary, Peripheral, and Neurovascular Guidewires--Performance Tests
and Recommended Labeling'' 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: Nicole Goodsell, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2309, Silver Spring, MD 20993-0002, 240-
402-6600.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Coronary, Peripheral, and Neurovascular
Guidewires--Performance Tests and Recommended Labeling.'' This guidance
updates and clarifies performance testing and labeling recommendations
to support a premarket notification (510(k) submission) for guidewires
intended for use in the coronary vasculature, peripheral vasculature,
and neurovasculature. The recommendations reflect current review
practices and are intended to promote consistency and facilitate
efficient review of these submissions. This guidance is also intended
to assist industry in designing and executing appropriate performance
testing to support a premarket notification and provides
recommendations for content and labeling to include in the submission.
FDA considered comments received on the draft guidance that appeared in
the Federal Register of June 15, 2018 (83 FR 27998). FDA revised the
guidance as appropriate in response to the comments. This guidance
supersedes ``Coronary and Cerebrovascular Guidewire Guidance,'' dated
January 1995 (available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080789.pdf).
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on coronary, peripheral, and neurovascular
guidewires performance tests and recommended labeling. 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 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy
[[Page 54611]]
of ``Coronary, Peripheral, and Neurovascular Guidewires--Performance
Tests and Recommended Labeling'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 16007 to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information. 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. 3501-3521). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:
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21 CFR part; guidance; or FDA
form Topic OMB control No.
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807, subpart E.................. Premarket 0910-0120
notification.
812............................. Investigational 0910-0078
Device Exemption.
``Requests for Feedback on Q-submissions...... 0910-0756
Medical Device Submissions: The
Q-Submission Program and
Meetings with Food and Drug
Administration Staff''.
800, 801, and 809............... Medical Device 0910-0485
Labeling
Regulations.
820............................. Current Good 0910-0073
Manufacturing
Practice (CGMP);
Quality System
(QS) Regulation.
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Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22194 Filed 10-9-19; 8:45 am]
BILLING CODE 4164-01-P