BIOPHOTONICS COMMERCIALIZATION: Changes in FDA device approval process could be costly

The winds of change are blowing at the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). Jeffrey Shuren is in as the new director and the Center has an ambitious strategic plan it's starting to implement. While Shuren has assured the device community that major changes are not in the offing, a look at the dates and descriptions of the strategic plan suggest the opposite.

What's getting the most attention is CDRH's 510(k) device approval process, a fast-track review that allows companies to show that their medical devices are as safe and effective as equivalent products already on the market. A 510(k) review is less stringent and less costly than the full-blown pre-market approval application (PMA) process (the standard fee for 510(k) submissions was $3,693 in fiscal year 2009, while for original PMA submissions it was $200,725). In addition, clinical data is usually not required for 510(k) approval.

Some worry that altering the system could make it difficult for small firms to bring products to market. The products created by many of these firms use emerging technologies that are usually tagged as Class III devices. Because these devices are considered more likely to place patients at high risk of injury or illness, they are usually required to undergo the more extensive PMA review process. However, if a company can show that its device is significantly equivalent to an existing product or has performance data for the product, FDA regulations allow the product to be reviewed under 510(k). Between 2003 through 2007, FDA reviewed over 2,400 510(k) submissions each year and cleared about 90 percent of the submissions for the U.S. market. These included 228 cleared submissions for Class III devices.

Results of scrutiny

The 510(k) process has come under a great deal of scrutiny during the past year. First a Government Accountability Office (GAO) report mandated by Congress suggested that the center review the 510(k) approval process because a greater number of devices tagged as Class III were being approved through 510(k) rather than the PMA cycle. The GAO report caused FDA to initiate its own 510(k) working group to examine the process and to ask the Institute of Medicine (IOM) to provide a comprehensive review of the entire process.

Exactly how the 510(k) process will change is unclear. The challenge for FDA is balancing safety and innovation. It's possible that Congress will get involved but it may be best for FDA to refine the clearance process based on input from industry and other advisors such as IOM. The strategic plan called for a meeting of industry and the public in late February with additional input from FDA staff in March. CDRH has set a September 30 deadline to begin implementing recommendations of the working group. The IOM report will not be completed until March 2011.

As part of the strategic plan CDRH also plans to take steps to improve the quality of clinical data submitted with PMAs. Though vague in its wording on just what needs improvement, the plan notes CDRH will review current guidance documents describing clinical trial design. The Center will likely issue a new guidance by the end of the year. This move could add to the cost of bringing new devices to market.