WASHINGTON A new review process by the Food and Drug Administration aimed at speeding the review times of medical device application is being outlined in a guidance advising applicants of when and how to contact the agency during a review cycle.
The new process is part of several changes under the reauthorized medical device user fee program. The process will apply to pre-market notification submissions, original pre-market approval applications, pre-market approval supplements, original biologics license applications, and biologics license applications supplements.
By using an interactive review system, the interaction between the FDA and applicants will increase, including the exchange of scientific and regulatory information, according to the guidance. The guidance is now available at the FDA’s website.