Document ID: FDA-2018-D-2494-0006
Agency: fda
Document Type: Notice
Title: Select Updates for Peripheral Vascular Atherectomy Devices—Premarket
Notification Submissions; Draft Guidance for Industry and Food and
Drug Administration Staff; Availability
Posted Date: 2020-07-13T04:00Z

[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Notices]
[Pages 41987-41989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15081]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2494]

Select Updates for Peripheral Vascular Atherectomy Devices--
Premarket Notification Submissions; Draft Guidance for Industry and 
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, Health and Human Services (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the availability of the draft guidance entitled ``Select Updates for 
Peripheral Vascular Atherectomy Devices--Premarket Notification 
(510(k)) Submissions.'' FDA has developed this draft guidance to 
propose select updates to certain sections of the existing FDA guidance 
document ``Peripheral Vascular Atherectomy Devices--Premarket 
Notification (510(k)) Submissions.'' This draft guidance is not final 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DATES: Submit either electronic or written comments on the draft 
guidance by September 11, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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

[[Page 41988]]

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-2494 for ``Select Updates for Peripheral Vascular 
Atherectomy Devices--Premarket Notification (510(k)) Submissions.'' 
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.govinfo.gov/content/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 
``Select Updates for Peripheral Vascular Atherectomy Devices--Premarket 
Notification (510(k)) Submissions'' 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: Jhumur Banik, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2223, Silver Spring, MD 20993-0002, 240-402-5239.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has developed this draft guidance to propose select updates to 
the FDA guidance document ``Peripheral Vascular Atherectomy Devices--
Premarket Notification (510(k)) Submissions.'' The existing guidance on 
atherectomy devices remains in effect, in its current form, until this 
draft guidance is finalized. FDA intends to incorporate this draft 
guidance into one final guidance document after obtaining and 
considering public comment on these select updates. FDA does not intend 
to substantively change the sections of the existing atherectomy 
guidance that are not affected by this select update.

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 ``Select 
Updates for Peripheral Vascular Atherectomy Devices--Premarket 
Notification (510(k)) Submissions.'' 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.

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 ``Select Updates for Peripheral Vascular Atherectomy 
Devices--Premarket Notification (510(k)) Submissions'' may send an 
email request to CDRH-Guidance@fda.hhs.gov to receive an electronic 
copy of the document. Please use the document number 19047 to identify 
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft 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 have been approved by OMB as listed in 
the following table:

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                                                             OMB control
      21 CFR part or guidance                 Topic              No.
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807, subpart E.....................  Premarket notification    0910-0120
820................................  Quality System            0910-0073
                                      Regulations.
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[[Page 41989]]

    Dated: July 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15081 Filed 7-10-20; 8:45 am]
BILLING CODE 4164-01-P