[Federal Register Volume 88, Number 72 (Friday, April 14, 2023)]
[Notices]
[Pages 23089-23091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07896]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5422]


Peripheral Percutaneous Transluminal Angioplasty and Specialty 
Catheters--Premarket Notification (510(k)) Submissions; Guidance for 
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Peripheral Percutaneous 
Transluminal Angioplasty (PTA) and Specialty Catheters--Premarket 
Notification (510(k)) Submissions.'' FDA is issuing this final guidance 
document to provide recommendations for 510(k) submissions for 
peripheral percutaneous transluminal angioplasty (PTA) balloons and 
specialty catheters (e.g., infusion catheters, PTA balloon catheters 
for in-stent restenosis (ISR), scoring/cutting balloons).

DATES: The announcement of the guidance is published in the Federal 
Register on April 14, 2023.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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

[[Page 23090]]

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-5422 for ``Peripheral Percutaneous Transluminal Angioplasty 
and Specialty Catheters--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, 240-402-7500.
     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, 240-402-7500.
    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 ``Peripheral Percutaneous Transluminal Angioplasty (PTA) and 
Specialty Catheters--Premarket Notification (510(k)) Submissions'' to 
the Office of Policy, 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: Eleni Whatley, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2267, Silver Spring, MD 20993-0002, 301-796-6372.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this guidance to clarify FDA's recommendations for 
testing and information to include in 510(k) submissions for PTA 
catheters and specialty catheters to promote consistency across 
submissions. These devices are catheter-based devices intended to treat 
lesions in the peripheral vasculature. This guidance expands on FDA's 
current thinking for testing of PTA balloon catheters and specialty 
catheters (e.g., infusion catheters, PTA balloon catheters for ISR, 
scoring/cutting balloons), and provides specific recommendations 
regarding performance testing and anatomy-specific assessments. This 
document supplements other FDA documents regarding the specific content 
requirements of premarket submissions.
    A notice of availability of the draft guidance appeared in the 
Federal Register of January 13, 2020 (85 FR 1812). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including addition of details and clarification for 
non-clinical test recommendations, and minor revisions to ensure 
consistency with FDA-recognized consensus standards and other FDA 
guidances.
    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 ``Peripheral Percutaneous Transluminal 
Angioplasty (PTA) and Specialty Catheters--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.

II. 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/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 and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Peripheral Percutaneous Transluminal 
Angioplasty (PTA) and Specialty Catheters--Premarket Notification 
(510(k)) Submissions'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number GUI00016018 and complete title to 
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by

[[Page 23091]]

OMB under the PRA. The collections of information in the following FDA 
regulations, guidance, and forms have been approved by OMB as listed in 
the following table:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
812............................  Investigational Device        0910-0078
                                  Exemption.
``Requests for Feedback and      Q-submissions..........       0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
50, 56.........................  Protection of Human           0910-0130
                                  Subjects and
                                  Institutional Review
                                  Boards.
58.............................  Good Laboratory               0910-0119
                                  Practice (GLP)
                                  Regulations for
                                  Nonclinical Laboratory
                                  Studies.
------------------------------------------------------------------------


    Dated: April 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07896 Filed 4-13-23; 8:45 am]
BILLING CODE 4164-01-P


