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GUIDANCE DOCUMENT

Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers October 1993

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

This document pertains to sharps containers and secondary sharps containers. A secondary container holds the sharps container, if leakage is possible (refer to OSHA regulation 29 CFR 1910.1030 (d) (4) (iii) (A) (3) ) .


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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:

Dockets Management
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.