Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities March 1993

GUIDANCE DOCUMENT

• Docket Number: FDA-2020-D-0957
• Issued by: Center for Devices and Radiological Health

The intent of this guidance document is to provide additional direction regarding information and data which should be submitted to FDA in a 510(k) submission for a sterilizer intended for use in a health care facility- Sterilizer technology is expanding at an accelerating pace.

Sterilizers can be complex in design and methods of sterilization are diverse. In spite of the complexity and diversity there are some common considerations that can be applied to virtually all 510(k) submissions for sterilizers. FDA believes it is prudent to provide 510(k) applicants, and other interested parties, information describing these common elements in order to improve the .quality of submissions and subsequently reduce the regulatory review processing time.

The guidance is based upon current publications, the literature, the combined experience and expertise of agency personnel involved in the evaluation of sterilization processes. Science .and the evaluation of medical devices are not static, rather they - are evolutionary. As such, FDA may periodically update this guidance, as necessary, to keep it current: Any comments on the content of this document are welcome and should be sent to the address noted under Section R.

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