United States of America. The Food and Drug Administration has announced the availability of a guidance entitled “Medical Devices Containing Materials derived from Animal Sources (Except for In Vitro Diagnostic Devices): Guidance for FDA Reviewers and Industry”, which is intended to provide recommendations for information that is to be included in premarket submissions (investigational device exemption, premarket approval applications) for medical devices that either contain or are exposed to animal-derived materials during manufacture.

Copies of the guidance document may be obtained from the Division of Small Manufacturers Assistance (DSMA), Center for Devices and Radiological Health (HFZ-220), FDA, 1350 Piccard Drive, Rockville MD 20850, USA (with two self-addressed adhesive labels) or from the Internet at: http://www.fda.gov/cdrh/ode/guid.html.

Reference: Federal Register 63(215): 60009-10 (1998).