83 FR 27998 - Coronary, Peripheral, and Neurovascular Guidewires-Performance Tests and Recommended Labeling; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 116 (June 15, 2018)

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Coronary, Peripheral, and Neurovascular Guidewires--Performance Tests and Recommended Labeling.'' This draft guidance provides recommendations for the information and testing that should be included in premarket submissions for guidewires intended for use in the coronary, peripheral, and neurovasculature. This draft guidance is not final nor is it in effect at this time.

[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)]
[Notices]
[Pages 27998-27999]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12825]


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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Tests and Recommended Labeling; Draft Guidance for Industry and Food 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the availability of the draft guidance entitled ``Coronary, Peripheral, 
and Neurovascular Guidewires--Performance Tests and Recommended 
Labeling.'' This draft guidance provides recommendations for the 
information and testing that should be included in premarket 
submissions for guidewires intended for use in the coronary, 
peripheral, and neurovasculature. This draft guidance is not final nor 
is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by August 14, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-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

[[Page 27999]]

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.thefederalregister.org/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 entitled 
``Coronary, Peripheral, and Neurovascular Guidewires--Performance Tests 
and Recommended Labeling'' to the Office of the Center Director, 
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: Jismi Johnson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993-0002, 301-796-6424.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and FDA staff entitled ``Coronary, Peripheral, and Neurovascular 
Guidewires--Performance Tests and Recommended Labeling.'' This draft 
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, peripheral, and 
neurovasculature. This draft guidance is 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. When final, this guidance will 
replace ``Coronary and Cerebrovascular Guidewire Guidance'' (https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080789.pdf) dated January 1995.

II. Significance of Guidance

    This draft guidance is being issued 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 ``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 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This draft 
guidance is also available at https://www.regulations.gov. Persons 
unable to download an electronic copy 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 draft guidance refers to previously approved collections of 
information found in FDA regulations and guidance. 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 part 807, subpart E 
have been approved under OMB control number 0910-0120; the collections 
of information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073; the collections of information in 21 CFR part 812 
have been approved under OMB control number 0910-0078; the collections 
of information in 21 CFR part 801 have been approved under OMB control 
number 0910-0485; and the collections of information in the guidance 
document ``Requests for Feedback on Medical Device Submissions: The 
Pre-Submission Program and Meetings with Food and Drug Administration 
Staff'' have been approved under OMB control number 0910-0756.

    Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12825 Filed 6-14-18; 8:45 am]
 BILLING CODE 4164-01-P