83 FR 33940 - Metal Expandable Biliary Stents-Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 138 (July 18, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 138 (July 18, 2018)
| Page Range | 33940-33941 | |
| FR Document | 2018-15294 |
[Federal Register Volume 83, Number 138 (Wednesday, July 18, 2018)] [Notices] [Pages 33940-33941] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15294] ----------------------------------------------------------------------- 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[Docket No. FDA-2018-D-1771] Metal Expandable Biliary Stents--Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Metal Expandable Biliary Stents--Premarket Notification (510(k)) Submissions.'' This draft guidance provides recommendations for information and testing that should be included in 510(k) submissions for metal expandable biliary stents and their associated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. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by September 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-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 [[Page 33941]] 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.thefederalregister.org/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 draft guidance document entitled ``Metal Expandable Biliary Stents--Premarket Notification (510(k)) Submissions'' to the Office of the Center Director, 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 draft guidance provides draft 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. FDA is updating this guidance to reflect current review practices. 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 draft 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. This draft guidance, when final, will supersede the guidance ``Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents,'' issued on February 5, 1998. 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 ``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 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 draft guidance 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 draft guidance refers to previously approved collections of information found in FDA regulations. 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 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR parts 50 and 56 have been approved under OMB control number 0910-0755; the collections of information in 21 CFR 56.115 have been approved under OMB control number 0910-0130; the collections of information in 21 CFR 50.23 have been approved under OMB control number 0910-0586; and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485. Dated: July 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-15294 Filed 7-17-18; 8:45 am] BILLING CODE 4164-01-P
![33940 Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices
regulatory science; and input into the requirements. If functioning as a this draft guidance before it begins work
Agency’s research agenda; and on medical device panel, a non-voting on the final version of the guidance.
upgrading its scientific and research representative of consumer interests and ADDRESSES: You may submit comments
facilities and training opportunities. It a non-voting representative of industry on any guidance at any time as follows:
will also provide, where requested, interests will be included in addition to
expert review of Agency-sponsored the voting members. Electronic Submissions
intramural and extramural scientific Further information regarding the Submit electronic comments in the
research programs. most recent charter and other following way:
The Committee shall consist of a core information can be found at https:// • Federal eRulemaking Portal:
of 21 voting members including a Chair www.fda.gov/AdvisoryCommittees/ https://www.regulations.gov. Follow the
and Co-Chair. The members, Chair, and CommitteesMeetingMaterials/Science instructions for submitting comments.
Co-Chair are selected by the BoardtotheFoodandDrug Comments submitted electronically,
Commissioner or designee from among Administration/ucm115356.htm or by including attachments, to https://
authorities knowledgeable in the fields contacting the Designated Federal www.regulations.gov will be posted to
of food science, safety, and nutrition; Officer (see FOR FURTHER INFORMATION the docket unchanged. Because your
chemistry; pharmacology; translational CONTACT). In light of the fact that no comment will be made public, you are
and clinical medicine and research; change has been made to the committee solely responsible for ensuring that your
toxicology; biostatistics; medical name or description of duties, no comment does not include any
devices; imaging; robotics; cell and amendment will be made to 21 CFR confidential information that you or a
tissue based-products; regenerative 14.100. third party may not wish to be posted,
medicine; public health and This document is issued under the such as medical information, your or
epidemiology; international health and Federal Advisory Committee Act (5 anyone else’s Social Security number, or
regulation; product safety; product U.S.C. app.). For general information confidential business information, such
manufacturing sciences and quality; and related to FDA advisory committees, as a manufacturing process. Please note
other scientific areas relevant to FDA please check https://www.fda.gov/ that if you include your name, contact
regulated products such as systems AdvisoryCommittees/default.htm. information, or other information that
biology, informatics, nanotechnology, identifies you in the body of your
Dated: July 12, 2018.
and combination products. Members comments, that information will be
Leslie Kux,
will be invited to serve for overlapping posted on https://www.regulations.gov.
Associate Commissioner for Policy. • If you want to submit a comment
terms of up to 4 years. Almost all non- [FR Doc. 2018–15297 Filed 7–17–18; 8:45 am] with confidential information that you
Federal members of this committee
BILLING CODE 4164–01–P do not wish to be made available to the
serve as Special Government
public, submit the comment as a
Employees. The core of voting members
written/paper submission and in the
may include one technically qualified DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
member, selected by the Commissioner HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
or designee, who is identified with
consumer interests and is recommended Food and Drug Administration Written/Paper Submissions
by either a consortium of consumer- Submit written/paper submissions as
[Docket No. FDA–2018–D–1771]
oriented organizations or other follows:
interested persons. The Committee may Metal Expandable Biliary Stents— • Mail/Hand delivery/Courier (for
also include technically qualified Premarket Notification (510(k)) written/paper submissions): Dockets
Federal members. The Commissioner or Submissions; Draft Guidance for Management Staff (HFA–305), Food and
designee shall have the authority to Industry and Food and Drug Drug Administration, 5630 Fishers
select members of other scientific and Administration Staff; Availability Lane, Rm. 1061, Rockville, MD 20852.
technical FDA advisory committees • For written/paper comments
(normally not to exceed 10 members) to AGENCY: Food and Drug Administration, submitted to the Dockets Management
serve temporarily as voting members HHS. Staff, FDA will post your comment, as
and to designate consultants to serve ACTION: Notice of availability. well as any attachments, except for
temporarily as voting members when: information submitted, marked and
(1) Expertise is required that is not SUMMARY: The Food and Drug identified, as confidential, if submitted
available among current voting standing Administration (FDA or Agency) is as detailed in ‘‘Instructions.’’
members of the Committee (when announcing the availability of the draft Instructions: All submissions received
additional voting members are added to guidance entitled ‘‘Metal Expandable must include the Docket No. FDA–
the Committee to provide needed Biliary Stents—Premarket Notification 2018–D–1771 for ‘‘Metal Expandable
expertise, a quorum will be based on the (510(k)) Submissions.’’ This draft Biliary Stents—Premarket Notification
combined total of regular and added guidance provides recommendations for (510(k)) Submissions.’’ Received
members), or (2) to comprise a quorum information and testing that should be comments will be placed in the docket
when, because of unforeseen included in 510(k) submissions for and, except for those submitted as
circumstances, a quorum is or will be metal expandable biliary stents and ‘‘Confidential Submissions,’’ publicly
lacking. Because of the size of the their associated delivery systems viewable at https://www.regulations.gov
Committee and the variety in the types intended to provide luminal patency of or at the Dockets Management Staff
amozie on DSK3GDR082PROD with NOTICES1
of issues that it will consider, FDA may, malignant strictures in the biliary tree. between 9 a.m. and 4 p.m., Monday
in connection with a particular This draft guidance is not final nor is it through Friday.
committee meeting, specify a quorum in effect at this time. • Confidential Submissions—To
that is less than a majority of the current DATES: Submit either electronic or submit a comment with confidential
voting members. The Agency’s written comments on the draft guidance information that you do not wish to be
regulations (21 CFR 14.22(d)) authorize by September 17, 2018 to ensure that made publicly available, submit your
a committee charter to specify quorum the Agency considers your comment on comments only as a written/paper
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![Federal Register / Vol. 83, No. 138 / Wednesday, July 18, 2018 / Notices 33941
submission. You should submit two Ave., Bldg. 66, Rm. G218, Silver Spring, number 1500070 to identify the
copies total. One copy will include the MD 20993–0002, 240–402–6510. guidance you are requesting.
information you claim to be confidential SUPPLEMENTARY INFORMATION: IV. Paperwork Reduction Act of 1995
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS I. Background This draft guidance refers to
CONFIDENTIAL INFORMATION.’’ The This draft guidance provides draft previously approved collections of
Agency will review this copy, including recommendations for 510(k) information found in FDA regulations.
the claimed confidential information, in submissions for metal expandable These collections of information are
its consideration of comments. The biliary stents and their associated subject to review by the Office of
second copy, which will have the delivery systems. These devices are Management and Budget (OMB) under
claimed confidential information intended to provide luminal patency of the Paperwork Reduction Act of 1995
redacted/blacked out, will be available malignant strictures in the biliary tree. (44 U.S.C. 3501–3520). The collections
for public viewing and posted on FDA is updating this guidance to reflect of information in 21 CFR part 807,
https://www.regulations.gov. Submit current review practices. The scope of subpart E, have been approved under
both copies to the Dockets Management this guidance is limited to metal OMB control number 0910–0120; the
Staff. If you do not wish your name and expandable biliary stents regulated collections of information in 21 CFR
contact information to be made publicly under 21 CFR 876.5010 (Biliary catheter part 820 have been approved under
available, you can provide this and accessories) and with product code OMB control number 0910–0073; the
information on the cover sheet and not FGE (Catheter, Biliary, Diagnostic). This collections of information in 21 CFR
in the body of your comments and you draft guidance applies only to biliary part 812 have been approved under
must identify this information as stents indicated for palliation of OMB control number 0910–0078; the
‘‘confidential.’’ Any information marked malignant strictures in the biliary tree. collections of information in 21 CFR
as ‘‘confidential’’ will not be disclosed It does not apply to biliary stents parts 50 and 56 have been approved
except in accordance with 21 CFR 10.20 indicated to treat benign strictures or under OMB control number 0910–0755;
and other applicable disclosure law. For stents intended to be used in the the collections of information in 21 CFR
more information about FDA’s posting vasculature, tracheal/bronchial tubes, or 56.115 have been approved under OMB
of comments to public dockets, see 80 other gastrointestinal anatomy. This control number 0910–0130; the
FR 56469, September 18, 2015, or access draft guidance, when final, will collections of information in 21 CFR
the information at: https://www.gpo.gov/ supersede the guidance ‘‘Guidance for 50.23 have been approved under OMB
fdsys/pkg/FR-2015-09-18/pdf/2015- the Content of Premarket Notifications control number 0910–0586; and the
23389.pdf. for Metal Expandable Biliary Stents,’’ collections of information in 21 CFR
Docket: For access to the docket to issued on February 5, 1998. part 801 have been approved under
read background documents or the OMB control number 0910–0485.
II. Significance of Guidance
electronic and written/paper comments Dated: July 12, 2018.
received, go to https:// This draft guidance is being issued Leslie Kux,
www.regulations.gov and insert the consistent with FDA’s good guidance
Associate Commissioner for Policy.
docket number, found in brackets in the practices regulation (21 CFR 10.115).
[FR Doc. 2018–15294 Filed 7–17–18; 8:45 am]
heading of this document, into the The draft guidance, when finalized, will
BILLING CODE 4164–01–P
‘‘Search’’ box and follow the prompts represent the current thinking of FDA
and/or go to the Dockets Management on ‘‘Metal Expandable Biliary Stents—
Staff, 5630 Fishers Lane, Rm. 1061, Premarket Notification (510(k))
DEPARTMENT OF HEALTH AND
Rockville, MD 20852. Submissions.’’ It does not establish any
HUMAN SERVICES
You may submit comments on any rights for any person and is not binding
guidance at any time (see 21 CFR on FDA or the public. You can use an Office of the Secretary
10.115(g)(5)). alternative approach if it satisfies the
requirements of the applicable statutes Office of the Assistant Secretary for
An electronic copy of the guidance
and regulations. This guidance is not Preparedness and Response;
document is available for download
subject to Executive Order 12866. Statement of Organization, Functions
from the internet. See the
SUPPLEMENTARY INFORMATION section for III. Electronic Access and Delegations of Authority
information on electronic access to the Persons interested in obtaining a copy Part A, Office of the Secretary,
guidance. Submit written requests for a of the draft guidance may do so by Statement of Organization, Functions,
single hard copy of the draft guidance downloading an electronic copy from and Delegations of Authority of the
document entitled ‘‘Metal Expandable the internet. A search capability for all Department of Health and Human
Biliary Stents—Premarket Notification Center for Devices and Radiological Services (HHS) is being amended at
(510(k)) Submissions’’ to the Office of Health guidance documents is available Chapter AN, Office of the Assistant
the Center Director, Guidance and at https://www.fda.gov/MedicalDevices/ Secretary for Preparedness and
Policy Development, Center for Devices DeviceRegulationandGuidance/ Response (ASPR), as last amended at 79
and Radiological Health, Food and Drug GuidanceDocuments/default.htm. This FR 70.535 (Nov. 26, 2014), 78 FR 25277
Administration, 10903 New Hampshire draft guidance is also available at (April 30, 2013), 78 FR 7784 (Feb. 4,
Ave., Bldg. 66, Rm. 5431, Silver Spring, https://www.regulations.gov. Persons 2013), 75 FR 35.035 (June 21, 2010) to
amozie on DSK3GDR082PROD with NOTICES1
MD 20993–0002. Send one self- unable to download an electronic copy realign the functions of ASPR to reflect
addressed adhesive label to assist that of ‘‘Metal Expandable Biliary Stents— the changes mandated by the 21st
office in processing your request. Premarket Notification (510(k)) Century Cures Act and to address ever-
FOR FURTHER INFORMATION CONTACT: Submissions’’ may send an email increasing manmade and naturally
April Marrone, Center for Devices and request to CDRH-Guidance@fda.hhs.gov occurring threats which degrade public
Radiological Health, Food and Drug to receive an electronic copy of the health, access to healthcare, access to
Administration, 10903 New Hampshire document. Please use the document emergency medical services and
VerDate Sep<11>2014 19:19 Jul 17, 2018 Jkt 244001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\18JYN1.SGM 18JYN1](https://thefederalregister.org/doc/83_FR_34078/page/2.svg)
Document Created: 2018-11-06 10:25:17
Document Modified: 2018-11-06 10:25:17
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by September 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| 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. | |
| FR Citation | 83 FR 33940 |
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