[Federal Register Volume 84, Number 144 (Friday, July 26, 2019)]
[Notices]
[Pages 36105-36107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15889]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1771]
Metal Expandable Biliary Stents--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 ``Metal Expandable
Biliary Stents--Premarket Notification (510(k)) Submissions.'' This
guidance provides recommendations for information and testing that
should be included in 510(k) submissions for metal expandable biliary
stents and their associated delivery systems intended to provide
luminal patency of malignant strictures in the biliary tree.
DATES: The announcement of the guidance is published in the Federal
Register on July 26, 2019.
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,
[[Page 36106]]
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-1771 for ``Metal Expandable Biliary Stents--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.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
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
``Metal Expandable Biliary Stents--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: April Marrone, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G218, Silver Spring, MD 20993-0002, 240-402-6510.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance provides recommendations for 510(k) submissions for
metal expandable biliary stents and their associated delivery systems.
These devices are intended to provide luminal patency of malignant
strictures in the biliary tree. The scope of this guidance is limited
to metal expandable biliary stents regulated under 21 CFR 876.5010
(Biliary catheter and accessories) and with product code FGE (Catheter,
Biliary, Diagnostic). This guidance applies only to biliary stents
indicated for palliation of malignant strictures in the biliary tree.
It does not apply to biliary stents indicated to treat benign
strictures or stents intended to be used in the vasculature, tracheal/
bronchial tubes, or other gastrointestinal anatomy.
FDA considered comments received on the draft guidance that
appeared in the Federal Register of July 18, 2018 (83 FR 33940). FDA
revised the guidance as appropriate in response to the comments. This
guidance updates and supersedes the guidance ``Guidance for the Content
of Premarket Notifications for Metal Expandable Biliary Stents,''
issued on February 5, 1998, to reflect current review practices.
II. Significance of Guidance
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 ``Metal Expandable Biliary Stents--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. This guidance is not subject to Executive
Order 12866.
III. 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. Persons unable to download an
electronic copy of ``Metal Expandable Biliary Stents--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 1500070 to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This 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. 3501-3520). The collections of information in
the following FDA regulations have been approved by OMB as listed in
the following table:
[[Page 36107]]
------------------------------------------------------------------------
21 CFR part Topic OMB Control No.
------------------------------------------------------------------------
807, subpart E................ Premarket 0910-0120
Notification.
812........................... Investigational 0910-0078
Device Exemption.
801........................... Medical Device 0910-0485
Labeling 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.
------------------------------------------------------------------------
Dated: July 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15889 Filed 7-25-19; 8:45 am]
BILLING CODE 4164-01-P