FDA Meeting to Review 510 (k) Medical Device Approvals

According to Reuters, the Food and Drug Administration will meet today to discuss changes to a program that oversees the way medical devices are approved for use in this country. Industry insiders consider this an important meeting since the FDA receives more than 3,000 medical device applications each year and the process has been controversial in the past.
The 510 (k) approval process has been dogged by allegations of fraud, safety problems, corruption, and conflicts of interest. Even the head of the committee, Dr. Daniel Schultz, prior to his resignation, admitted to problems with the process. Schultz admitted that the committee was often pressured to approve medical devices against the committee’s better judgment.
The meeting will be divided as follows: 1)issues related to predicate devices, which are previously cleared devices that may support a manufacturer’s claim of substantial equivalence; 2)issues related to new technologies and scientific evidence; 3)issues related to practices the FDA adopted in response to a high volume of submissions; and 4)issues related to post-market surveillance and new information about marketed devices.