FDA’s Proposed Changes in 510(k) Process Are Still in Their Own Process
By James M. Connolly in Mass. High Tech, June 22, 2011
“Our members are very concerned that the FDA is proposing drastic changes to a program that has served the patient and health-care delivery system for many years. While review of a 35-year-old program is to be applauded, some of the changes that they have proposed MassMedic members feel will stifle innovation,” said Tom Sommer, president of the industry group MassMEDIC.