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GUIDANCE DOCUMENT

Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions Guidance for Industry July 1998

Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document represents the agency’s current thinking on the use of consensus standards for abbreviated submissions for 510(k) Premarket notifications for latex condoms for men. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.


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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0957.

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