- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
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.