For the report, called "FDA Impact on U.S. Medical Technology Innovation," Stanford researchers surveyed 204 medical technology companies about the U.S. regulatory process. The report, which is available online as a PDF, states that the average cost to take a 510(k) product from concept to market is $31 million, and that roughly 77% of that amount is spent on tasks related to FDA regulation. High-risk PMA costs averaged $94 million, the report states, with $75 million of that spent on "stages linked to the FDA."
|FDA’s performance metrics for 510(k) submissions in FY 2008 and FY 2009. The agency has the potential to exceed both the tier 1 and tier 2 performance goals for FY 2009. Source: FY 2009 Performance Report to Congress.|
Authors of the study pointed to unpredictable, inefficient, and expensive regulatory processes as a main cause of such a high cost. In general, survey respondents characterized the regulatory process as fraught with disruptions and delays. For example, 44% of participants indicated that part-way through the premarket regulatory process they experienced untimely changes in key personnel, including the lead reviewer and/or branch chief responsible for the product’s valuation. A total of 34% of respondents also reported that appropriate FDA staff or physician advisors to the FDA were not present at key meetings between the FDA and the company.
A table of FDA's reported averages for 510(k) review is included above. Check out the December issue of MD+DI (coming soon) to see more data collected by the editors.