FDA Device Backlog Grew in 1993

The backlog of medical devices awaiting approval by the Food and Drug Administration has grown substantially despite a series of initiatives implemented last year to speed product approvals (SCAN 7/14/93). Increased delays are having a profound effect on the medical device industry, according to former FDA staffer James S. Benson.

Benson joined the Health Industry Manufacturers Association (HIMA) as senior vice president of technology and regulatory affairs a year ago, after leaving the FDA where he was director of the Center for Devices and Radiological Health (CDRH). He delivered stark figures on the size of the FDA backlog in an address to the Cardiovascular Science and Technology Conference in Washington, DC, last month.

According to statistics HIMA received from the FDA:

• The total number of 510(k) device applications at CDRH awaiting reviewer action stood at 5157 in fiscal 1993 (end-September), compared to 3951 in 1992 and 2291 in 1991;
• The average review time for an FDA decision on a 510(k) application was 195 days, compared to 126 days in 1992 and 102 days in 1991;
• Average approval time for new pre-market approval applications (PMAs) rose to 799 days in 1993, compared to 633 days in 1991.
• CDRH reviewers made decisions on 5073 applications in the last fiscal year, while manufacturers submitted 6288 in the same period.

These numbers present a picture of an agency that is running to stand still. Benson's replacement at CDRH, Dr. Bruce Burlington, introduced four major reforms to the center's device review process, but as the numbers indicate, the initiatives have not begun to clear up the logjam.

The device approval backlog is increasing costs for device companies and could eventually reduce research and development activities, Benson told the conference. Companies are moving production and R&D facilities overseas, and investors are becoming leery of pouring money into companies developing products that must be cleared by the FDA.

While the CDRH reforms are needed, better communication between industry and the center is just as crucial, he said. In particular, the FDA should give industry clear guidance on what information will be required for device approval.

"Industry's ability to consistently prepare quality submissions is directly related to a clear understanding of CDRH's ground rules," Benson said. "The current prolonged review times and resulting backlog were created, in part, because device reviewers lack information for a sufficient scientific basis on which to make clearance and approval decisions. Without clear agency guidance, reviewers are reluctant to make decisions."

Industry and FDA have sparred over this point in the past. Last year the FDA released the Temple Report, a review of the quality of device applications, co-authored by Dr. Robert Temple, director of the Office of Drug Evaluation (SCAN 3/10/93). The report found that poor-quality applications have exacerbated the approval backlog. The device industry, however, responded that the device applications studied in the report were not representative of the majority filed by industry.