Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers October 1993
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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) ) .
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.