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Guidance Issuing OfficeCenter for Devices and Radiological Health
The intent of this guidance document is to provide 510(k) applicants specific additional directions regarding information and data which should be submitted to FDA in a 510(k) submission for surgical gowns and surgical drapes. A safe and effective barrier device to protect both the surgical patient and the operating room personnel from the transfer of microorganisms or body fluids during surgical procedures is important in preventing infections. Comprehensive, scientifically sound criteria for the evaluation of surgical gowns or surgical drapes is essential to help ensure that these devices are safe and effective for their intended use when used according to their labeling. FDA recognizes the importance of providing applicants, and other interested parties, the agency's 510(k) submission criteria for surgical gowns or surgical drapes in order to facilitate assembly of necessary data, to maintain consistency of review, and to provide for a more efficient regulatory process.
The document expresses FDA's recommendations as of the date noted on the cover page. There is ongoing research and debate with regard to the design and test methods for surgical gowns and surgical drapes. Despite this state of flux, FDA finds it necessary at this time to document its 510(k) submission criteria in order to expedite the availability of safe and effective surgical gowns and surgical drapes. FDA expects that this document will stimulate and/or accelerate development of test methods and specific validation procedures by the scientific community and regulated industry. The document is not static but will be periodically revised to keep it current with state of the art developments in this area. Comments on the document are welcome and should be sent to the address noted on page 11.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
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-2020-D-0957.