[Federal Register Volume 85, Number 8 (Monday, January 13, 2020)]
[Notices]
[Pages 1812-1813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00296]
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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Catheters--Premarket Notification (510(k)) Submissions; Draft Guidance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the availability of the draft guidance entitled ``Peripheral
Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters--
Premarket Notification (510(k)) Submissions; Draft Guidance for
Industry and Food and Drug Administration Staff.'' The FDA is issuing
this draft guidance document to provide recommendations for 510(k)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).
This draft guidance is not final nor is it in effect at this time.
DATES: Submit either electronic or written comments on the draft
guidance by March 13, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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 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-2019-D-5422 for ``Peripheral Percutaneous Transluminal Angioplasty
(PTA) and Specialty Catheters--Premarket Notification (510(k))
Submissions; Draft Guidance for Industry and Food and Drug
Administration Staff.'' 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
[[Page 1813]]
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
``Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty
Catheters--Premarket Notification (510(k)) Submissions; Draft Guidance
for Industry and Food and Drug Administration Staff'' 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: 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
The FDA is issuing this draft guidance to clarify the 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
draft guidance expands on the 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.
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 ``Peripheral
Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters--
Premarket Notification (510(k)) Submissions; Draft Guidance for
Industry and Food and Drug Administration Staff.'' 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Peripheral
Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters--
Premarket Notification (510(k)) Submissions; Draft Guidance for
Industry and Food and Drug Administration Staff'' may send an email
request to [email protected] to receive an electronic copy of
the document. Please use the document number 16018 and complete title
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 and guidance 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 on Q-Submissions.......... 0910-0756
Medical Device Submissions:
The Pre-Submission Program and
Meetings with Food and Drug
Administration Staff''.
801............................ Medical Device Labeling 0910-0485
Regulations.
820............................ Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality System
(QS) Regulation.
50, 56......................... Protection of Human 0910-0755
Subjects: Informed
Consent; Institutional
Review Boards.
56............................. Institutional Review 0910-0130
Boards.
58............................. Good Laboratory 0910-0119
Practice (GLP)
Regulations for
Nonclinical Laboratory
Studies.
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Dated: January 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00296 Filed 1-10-20; 8:45 am]
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