[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]
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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.
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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
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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
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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:
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OMB control
21 CFR part or guidance Topic No.
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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.
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Dated: April 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07896 Filed 4-13-23; 8:45 am]
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