FDA process for approving new medical devices examined in study

Medical innovation saves lives, but each drug and device requires careful scrutiny by the Federal Drug Administration before being deemed safe to market. But does the federal agency take too long in its approval process?

Dr. Josh Makower says yes. The consulting professor of medicine at Stanford University co-wrote a study of 200 medical technology companies and reports his findings in this column by Nicole Brochu of the South Florida Sun Sentinel. The column reads in part:

“For low- and moderate-risk devices, the process to navigate the FDA took companies on average three months to two years longer for a green light than it did for a similar approval from European regulators. For higher-risk devices, the discrepancy was greater — the process in the United States took three and a half years, or five times as long as Europe, to grant approval.” The full study can be downloaded from the National Venture Capitalist Assn., which supported the study.

The FDA disputed the findings in this Health Blog from the Wall Street Journal. Earlier this year, the FDA took steps to become more “transparent” by launching a Web page that explains its regulatory decisions. Here’s a list of FDA medical device approvals and clearances as well as the agency’s more comprehensive description of how the process works.

Stay tuned, as there are likely to be more reactions to this study.