Medical Devices Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers." This draft guidance document provides specific recommendations on data and information medical device manufacturers should submit in premarket notifications (510(k)s) for biological indicators intended to monitor sterilizers used in health care facilities. This draft guidance is neither final nor is it in effect at this time.