Medical device manufacturers make changes to existing products all the time. But how does the manufacturer decide when to handle that change internally — that is to say, using a letter-to-file — versus notifying the FDA via a special 510(k) or PMA supplement? The choice is not always clear.
Although FDA has issued several guidances on this important topic over the years (including this one), it continues to cause problems for medical device manufacturers — not only with the FDA, but in some cases with the FBI!
In this podcast, Michael Drues, president of Vascular Sciences and author of the Guerilla Regulatory Strategy article series, discusses medical device change management with Jim Pomager, executive editor of Med Device Online.