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GUIDANCE DOCUMENT

Surgical Staplers and Staples for Internal Use - Labeling Recommendations Guidance for Industry and Food and Drug Administration Staff April 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Surgical Staplers and Staples for Internal Use - Labeling Recommendations

Submit Comments by 06/23/2019

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-1262


Docket Number:
FDA-2019-D-1262
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The Food and Drug Administration (FDA) is issuing this guidance to provide labeling recommendations for surgical staplers and staples for internal use. These labeling recommendations are being issued because malfunctions and misuse associated with these devices have resulted in serious adverse events, including deaths.

FDA believes that the labeling recommendations in this guidance would help promote the safe and effective use of surgical staplers and staples for internal use by helping manufacturers develop labeling with information about specific risks, limitations, and directions for use of the device.