Like the audience in Minnesota, many attendees at the most recent meeting complained about a host of issues in getting medical devices approved. These problems included delays at FDA, mixed signals, and unpredictability. Manufacturers, particularly start-up firms, said that these issues caused confusions and threatened their businesses.
“To the investors in my company, it has become increasingly clear that prestated and prenegotiated rules of the game can now be capriciously and arbitrarily changed, and that good science no longer suffices for FDA clearance,’’ said attendee Eric Bornstein, chief science officer at Nomir Medical Technologies.
Shuren admitted that “There’s much the center can do to be consistent with industry. We have cases where the manufacturer is right that we can do better.’’