The medical device industry and consumer advocates offered starkly different visions of the safety of the expedited approval process for devices in comments filed Monday.
While the Advanced Medical Technology Association (AdvaMed) argues for modernizing the process while arguing that it's safe, Public Citizen counters that it "has failed to consistently protect the public health." The comments come as the Food and Drug Administration is considering more than 60 changes to the expedited approval process for low- and moderate-risk devices, known as pre-market review or 510(k).
In its 107 pages of comments, AdvaMed argues that there's been a "significant deterioration in the efficiency and consistency of the 510(k) review process. If these trends are not reversed, there will be a long-term negative impact on patient access to new and improved treatments and to investment by and in device companies and others in the development of new products." The group has called for increased reviewer training, development of additional guidance and greater communication of reviewer decision rationale to prevent delays and inconsistencies in the program.
Public Citizen on the other hand believes the FDA should do more to "keep dangerous and ineffective medical devices from the market."