By: Mark Crawford
Medical device manufacturers (MDMs) know all too well how the FDA 510(k) review process of premarket applications for devices can seem to take forever. Although it’s easy to blame the FDA, there is a lot MDMs can do to expedite the process.
According to a new FDA guidance, total review time—the time it takes FDA to review an application and for companies to respond to the FDA’s questions—has increased, primarily due to companies taking more time to respond to requests for additional information. In addition, the number of Additional Information (AI) letters per submission the FDA sends out (“cycles”) has also increased. (more…)