Apr 2, 2012

A new report from the US Government Accountability Office (GAO) provides yet more data showing that total average review times for FDA 510(k) medical device applications has increased despite the regulator’s meeting other 510(k)-related performance goals.

Specifically, the average total time from 510(k) application submission to final decision increased from 100 days in 2005 to 161 days in 2010—an increase of 61%. However, the report also points out that the FDA has reviewed more than 90% of 510(k) submissions within 90 days each year since 2005; the agency was also able to review 98% of all 510(k) submissions within 150 days. It is important to note that FDA “review times” exclude the time it takes for manufacturers to respond to FDA requests for additional information on their submissions, whereas the total time periods evaluated by the GAO do include time required to respond to additional requests for information from the agency.

Furthermore, the GAO found inconsistencies when it came to FDA reviews of pre-market approval (PMA) applications. For “original” or standard PMAs, the FDA met its performance goals for four out of seven years that those performance goals were in place, but for “expedited” PMAs—available for devices deemed to treat or diagnose life-threatening diseases and meet unmet medical needs—the FDA met its performance goals for only two of the seven years of record.

GAO investigators interviewed industry and consumer advocacy groups as part of its study. Based on these interviews, the report identifies four most common complaints regarding dealing with the FDA for medical device clearances and approvals:

  1. Inadequate communication between FDA reviewers and stakeholders
  2. Lack of predictability and consistency in reviews
  3. Increasing time to final decisions
  4. Insufficient assurance from the FDA regarding devices’ safety and effectiveness

The GAO study clearly breaks no ground in terms of FDA medical device review times—other studies have also come to similar conclusions. What these findings perhaps most importantly demonstrate, however, is the need for manufacturers to make every effort to ensure they do not have to deal with additional requests for information from the regulator. 


  • Stewart Eisenhart