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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Notices Instructions: All submissions received must include the Docket No. FDA
2019D1262 for Surgical Staplers and Staples for Internal UseLabeling Recommendations. 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, 2404027500.
Confidential SubmissionsTo 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 FDAs 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-201509-18/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, 2404027500.
You may submit comments on any guidance at any time see 21 CFR
10.115g5.
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
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document entitled Surgical Staplers and Staples for Internal UseLabeling Recommendations 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 209930002. Send one selfaddressed adhesive label to assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT:

George Gibeily, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4660, Silver Spring, MD 209930002, 3017960276.
SUPPLEMENTARY INFORMATION:

I. Background FDA is announcing the availability of a guidance for industry and FDA staff entitled Surgical Staplers and Staples for Internal UseLabeling Recommendations. Surgical staplers for internal use are specialized prescription devices used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses. Surgical staplers and staples for internal use may be indicated for use in a wide range of surgical applications, including but not limited to gastrointestinal, gynecologic, and thoracic surgery. FDA developed this guidance because we had become aware of a large number of adverse events associated with use of both surgical staplers and staples for internal use. Both device misuse and device malfunctions are root causes of these adverse events. FDA believes that these problems may be mitigated by providing specific information about the risks, limitations, and directions for use in the labeling for the surgical staplers and staples for internal use.
This guidance is intended to provide recommendations for information that should be included in the product labeling for surgical staplers and staples for internal use, including contraindications, warnings, directions for use, and technical characteristics and performance parameters. Elsewhere in this issue of the Federal Register, FDA is announcing the final reclassification of surgical staplers for internal use from class I to class II with special controls. Some of the labeling recommendations in this guidance are intended to provide additional recommendations in order to help manufacturers comply with the labeling requirements as part of the special controls for surgical staplers for internal use.

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A notice of availability of the draft guidance appeared in the Federal Register of April 24, 2019 84 FR
17174. FDA considered comments received and revised the guidance as appropriate in response to the comments, including revisions to the contraindications and warnings to avoid being overly prescriptive and not interfere with physicians decision making under practice of medicine where appropriate. Revisions were also made to refine the directions for use and technical characteristics recommendations in response to feedback, as also described in the final reclassification of surgical staplers for internal use announced elsewhere in this issue of the Federal Register. FDA
also added the relevant special controls language in order to make it clear what are requirements under the special controls and what are further clarifying recommendations.
This guidance is being issued consistent with FDAs good guidance practices regulation 21 CFR 10.115.
The guidance represents the current thinking of FDA on Surgical Staplers and Staples for Internal UseLabeling Recommendations. 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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https www.regulations.gov. Persons unable to download an electronic copy of Surgical Staplers and Staples for Internal UseLabeling Recommendations may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 18013 and complete title to identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does refer to previously approved collections of information. Therefore, clearance by the Office of Management and Budget OMB under the Paperwork Reduction
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