Timeliness and Quality of Medical Device Clearance Applications to the FDA

02.22.11 Lindsay Morris

On February 17th, the House Energy and Commerce Committee’s Health Subcommittee held a hearing on the impact of medical device regulation on jobs and patients. At that hearing, Dr. Jeffrey E. Shuren, Director of the FDA’s Center for Devices and Radiological Health (CDRH) stated that the medical device industry plays a role in increased wait times that many device manufacturers see as they travel through the FDA clearance process. He stated that “poor quality submissions” (Gray Sheet’s “Shuren On The Hill: Industry Should Take More Blame For Review Delays”) by industry slow the approval process for FDA reviewers. Obviously, industry’s interest is in speeding clearance times and improved predictability at the Agency that’s why we so strongly support clear FDA guidance documents and have even worked with stakeholders to develop draft guidance for FDA to review.  However, if the quality of applications industry submits is deteriorating we would be extremely interested in learning what that means and the magnitude of the problem so that we can address it as quickly as possible.