FDA Lags On 510(k) Medical Device Approvals

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 09 Nov 2009 - 4:00 PDT


According to MassDevice.com, the online business journal of the medical device industry, medical device approval times under the Food & Drug Administration's 510(k) clearance process jumped 30 percent between 2005 and 2008. MassDevice's exclusive investigation of 10 years of FDA data, Eye on the FDA: H1 2009, shows that approval times for medical devices increased nearly 2 percent - while the number of 510(k) applications declined more than 19 percent - even as the FDA's budgets and staff levels rose.

In fact, contrary to its own goal of clearing 90 percent of 510(k) applications for medical devices in 90 days, Eye on the FDA: H1 2009, 2009 demonstrates that decision times are trending significantly longer. For example, the average decision time for 510(k) approvals was 113 days in 2008, compared with 87 days in 2005, an increase of 30 percent in just three years.

"Medical device manufacturers should reconsider all timelines associated with the 510(k) clearance process for medical technology," said MassDevice Publisher Brian Johnson. "Taking into account a new, more stringent approach on the part of the FDA's new leadership and a comprehensive institutional examination of the 510(k) process that will likely result in recommendations for change, the regulatory path for new devices is likely to become longer, more costly and more onerous in the near future."

Eye on the FDA: H1 2009, examines other key trends and data on the FDA's 510(k) approvals process. Here's a small sampling:

- Average decision times for 510(k) clearances
- Average decision times by device classification
- 10-year history of 510(k) clearance decision times and device classifications
- A list of all the companies and devices that received 510(k) approvals during H1 2009
- The most active geographic regions for 510(k) approvals, by device classification
- Hottest sectors and device classifications

MassDevice's new report, Eye on the FDA: H1 2009,, provides important insight into the trends shaping how most medical devices make it into the marketplace.

Source
MassDevice.com

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