Issue Date: January 7, 2002
Issued by: Center for Devices and Radiological Health
Topic(s): Postmarket,
Status: Final
Sterilized Convenience Kits for Clinical and Surgical Use: Final Guidance for Industry
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.
Download the Guidance Document
