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GUIDANCE DOCUMENT

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

Download the Final Guidance Document
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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Submit Comments Online

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.

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