Can published literature be used to support an IVD premarket submission?
CDRH has developed a guidance document entitled “Guidance for Industry; Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review,” which can be found on the CDRH website. CDRH and CBER believe that the principles outlined in this guidance are applicable to other submissions, specifically those for a 510(k), PMA, and HDE. (See the Glossary for definitions of these submission types.) • Can data from studies performed outside of the United States ( U.S.) be used to support an IVD premarket submission? Yes. FDA recognizes there may be a need to go outside of the U.S. to find adequate numbers of subjects for certain disease states, conditions, or pathogens. The PMA regulation contains information regarding research conducted outside of the U.S. (21 CFR 814.15). FDA can also accept data from foreign studies in support of 510(k)s . • Can foreign/international data be used as the sole support of
