Document ID: FDA-2018-D-1771-0005
Agency: fda
Document Type: Notice
Title: Metal Expandable Biliary Stents— Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2019-07-26T04:00Z

[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 CDRH-Guidance@fda.hhs.gov 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