FDA rapped for unpredictability on 510(K) approval process

Acknowledging the need for greater transparency and coordination with manufacturers, the FDA stands by its stringent and notoriously slower 510(k) medical device approval process relative to other countries. Yet device manufacturers complain that the agency's unpredictable procedures, not its speed, are the key reason for industry's growing introduction of products outside the U.S. market. As the FDA gears up to make major changes to the approval process for medical devices in September, including a 25-step improvement plan, Northwestern University in Chicago released a study of 356 representatives of medical device manufacturers with experience in the FDA 510(k) approval process. The National Press Club hosted a forum this week with the study's lead investigators and a panel that included current and former executives from the FDA and medical industry, as well as consultants.