FDA Asks Institute Of Medicine To Evaluate 510(k) Review Process

Here we go again. The question as to the effectiveness of the 510(k) process is under review to see how this pre-market notification process can be improved.

The FDA has commissioned the Institute of Medicine to assess its 510(k) pre-market review process for medical devices and help determine how the oft criticized program can be improved, the agency announced Sept. 23.

The 510(k) clearance program is under scrutiny from some members of Congress and the public who say it allows products onto the market without adequate safety and effectiveness review.

Congress wanted to introduce legislation earlier this year with a provision that would have required IOM to perform a top-to-bottom assessment of the 510(k) program by September 2010.

The FDA has publicly defended the 510(k) program against its critics, but by commissioning the $1.3 million IOM study, FDA is beating Congress to the punch.

The IOM study will pose two key questions: Does the current 510(k) process optimally protect patients and promote innovation in support of public health? And, if not, what legislative, regulatory or administrative changes are recommended to achieve the goals of the 510(k) process?

The 510(k) program was established in 1976 by the Medical Device Amendments. It was changed to include Safety and Efficacy by the Safe Medical Device Act of 1992. The Medical Device technology and the device industry have changed “dramatically,” FDA says, “making it an appropriate time for CDRH to review the adequacy of the pre-market notification program.”

The device industry is, by and large, protective of the current 510(k) program and says that many of the criticisms are based on false impressions.

We wait and see what comes out of these studies. But, can the industry continue to put with more and more expense and time in dealing with the Agency. How the findings and the possible changes would affect the innovation provided by the small medical device manufacturer could cause undue delays in new technologies getting to the public.