On 19 January 2011, the FDA unveiled its much-awaited proposal for changes to the 510(k) process. Medical device industry representatives were generally pleased with the modest scope of the proposal. In a press release, AdvaMed president Stephen J. Ubl called the plan “clearly a good first step that will address some of the major problems with the program.” Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA) commended “FDA leadership and staff for working with various stakeholders in an open and constructive process to develop consensus proposals that improve patient access to safe and effective therapies.” The NY Times quoted Medtronic CEO William A. Hawkins as stating “This is a more balanced approach that sends a positive signal to industry that the F.D.A. is engaged, listening and concerned.”
Patient safety advocates were underwhelmed. Public Citizen’s Sidney Wolfe stated “the FDA is not being forceful enough about improving the safety and effectiveness of new devices.” Dr. Rita Redberg (UCSF, Editor of Archives of Internal Medicine) told theHeart.org that she is “worried about the implanted high-risk devices that are getting cleared without any data. There are lots of examples of stents, inferior vena cava filters, heart valves, that are [cleared through 510(k) but] not low risk.”
But is the FDA’s modest proposal really a good outcome for the device industry?