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GUIDANCE DOCUMENT

Sterilized Convenience Kits for Clinical and Surgical Use Final Guidance for Industry January 2002

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

The Center for Devices and Radiological Health (CDRH) continues to have concerns about finished device components that are assembled into clinical or surgical convenience kits and the kit is then sterilized. In some cases, the finished device is actually being sterilized for a second time. Some components may be adversely affected by further processing in the sterilization process. For the purposes of this guidance, a finished device component in a convenience kit is a device in finished form held for sale to an end user that is suitable for use or capable of functioning, whether or not it is packaged, labeled or sterilized. Please ensure that your sterilization process does not adversely affect the finished components in your kits.

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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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