Originally published February, 1997
Even after six months of operation, FDA's third-party product review pilot program isn't quite off the ground. Deemed capable by FDA of handling as many as 1500 premarket notifications a year, third parties have received only three since the program's inception.
The results of a recent informal MD&DI survey and comments from industry and third parties indicate that such low use can be attributed to a number of factors: the limited number of devices eligible for third-party review, the cost of contracting a third-party reviewer, and concerns about the reliability of the reviews.
The pilot, which began on August 1, 1996, was designed to offer manufacturers an alternative route for the review of low- to moderate-risk devices, one that potentially could yield faster product reviews than FDA. It was also intended to lessen FDA's workload by offloading certain 510(k) applications to third parties, enabling FDA to focus on higher-risk devices. The agency had originally intended to judge the program's performance during its second year, but concern about its infrequent use has prompted FDA to invite industry and others to comment on how to make the program more attractive to manufacturers. Otherwise, if pilot use remains low, FDA won't have enough data to test the feasibility of third-party review.
"FDA had a good philosophical approach, but a bad implementation," asserts Jeff Kimbell, executive director of the Medical Device Manufacturers Association (MDMA; Washington, DC). Arguing that manufacturers do not want to pay third parties for reviews that FDA is already completing in less than 90 days, Kimbell suggests that FDA expand the pilot to include Class II products that do not need clinical trials for approval.
Dee Simons, associate vice president at the Health Industry Manufacturers Association (Washington, DC), predicted such a problem with the program last year in a June 3 letter to FDA. "Manufacturers may not want to contract with a third party because FDA is already meeting the 90-day review time for most of the devices in the program." She also noted that FDA would not be significantly reducing its workload, estimating that the "review time saved is probably less than 5%."
Carole Stamp, 510(k) program manager at TÜV Product Service (New Brighton, MN), one of the seven third parties recognized by FDA, agrees that the number of eligible Class II devices needs to be increased. Citing many inquiries from manufacturers of Class II devices that are not eligible for participation in the program, Stamp believes that "these manufacturers seem to be more receptive to the third-party review program because they see a potential to significantly reduce the review time." She concludes that "as more Class II devices become eligible, manufacturer participation will increase."
MD&DI readers expressed other concerns. David Kunin, a manufacturing consultant who has experience with in vitro diagnostics, electronics, and disposables, asks, "Why pay twice for a tax-supported FDA activity?" MDMA's Kimbell, who represents 130 entrepreneurial device manufacturers, agrees that the additional cost is a burden on smaller companies.
Susan Alpert, director of FDA's Office of Device Evaluation (ODE), however, says FDA is surprised that more manufacturers aren't using the program. She realizes that it costs them additional money, but "generally all of us are willing to spend a little extra money when we can get something in return."
Another issue raised by readers was the uncertainty that third parties could perform reviews as fast as or faster than FDA. But, according to Nancy Sauer, president of RDD Consultants, Inc. (Louisville, CO), her firm's recent completion of the only two third-party reviews submitted to FDA and the agency's ability to finish its reviews, all in 51 days, shows that third parties and FDA can work together to reduce review time. Sauer explains that additional studies were required for these reviews and complete 510(k) submissions should be reviewed more quickly.
ODE's Alpert also feels that the program offers manufacturers the "opportunity to cut time from the review process by negotiating with an entity that doesn't have a lot of other work on its plate." Speaking at FDLI's annual meeting last December in Washington, DC, she noted that in-agency 510(k) reviews comparable to the ones completed by RDD Consultants were running a little over 100 days, a review time twice that required for the two reviews completed under the program.
Finally, readers are concerned about a third party's ability to handle 510(k) submissions. "Factors that would sway me to use--or not to use--a third-party reviewer include the third party's understanding of technology, product requirements, and the marketplace," explains Paul Martakos, senior research scientist at Atrium Medical Corp. (Hudson, NH).
Kimbell isn't surprised at such skepticism. He believes that until FDA includes recognized leaders in medical treatment, manufacturers will be concerned about the lack of expertise.--Daphne Allen