Third-Party 510(k) Reviews Gaining Popularity

Originally Published MDDI October 2003

NEWSTRENDS

Erik Swain

According to FDA statistics, 510(k) submissions are receiving market clearance faster when third parties review them. It appears that device companies are taking notice, as the practice has spiked in popularity recently.

The FY 2002 annual report of CDRH's Office of Device Evaluation (ODE) notes that the agency made decisions on 132 510(k) submissions received by third parties during the year, up from 99 in FY 2001. That number should be easily surpassed in FY 2003, as the ODE had made 120 decisions on third-party-reviewed submissions as of July 31, 2003. 

The report attributes the increase to an expanded pilot program that went into effect in 2001. Originally, third parties could review submissions for Class II devices only if the agency had written a specific guidance for that device. The expanded pilot program allows third-party review of about 460 Class II devices without a specific guidance. 

Those who are using the program are seeing significant reductions in review time: 510(k) submissions reviewed by third parties in FY 2002 received marketing clearance about 30% faster than comparable 510(k)s reviewed entirely by FDA, the report states. The average time between a third-party reviewer receiving a submission and ODE making a substantial equivalence decision was 70 days for non-pilot-program devices and 105 days for pilot-program devices. The comparable figures are 105 days for nonpilot devices and 147 days for pilot devices that FDA reviewed itself. 

Interest in third-party use is growing stronger, and there may be reasons beyond the pilot-program expansion. Most months between July 2002 and April 2003, 3–4% of the 510(k) submissions FDA decided on were reviewed by third parties. But those numbers are jumping significantly. In May 2003, third-party-reviewed applications accounted for 6.0% of the total; in June 2003, 6.4%; and in July 2003, 7.0%.

One theory for the spike: user fees. “Before the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), third-party reviewers were charging for doing 510(k)s, and FDA couldn't,” said Harvey Rudolph, PhD. Rudolph is global program manager for medical devices at Underwriters Laboratories Inc. (UL; Northbrook, IL), one of 14 bodies (accredited persons) authorized to be a third-party reviewer. “Then FDA started charging about $2200, which is considerably less than what we would charge, but it narrowed the gap. Now, FDA is raising the fee to $3400, and our prices are not going up that much, so the differential is even smaller. I expect to see a big jump after October in addition to what we're seeing now.” Third-party review submissions are exempt from the FDA user fees.

The third-party reviewers are positioning themselves for this expected surge in interest. Two firms, Medtech Review LLC (Minnetonka, MN) and Regulatory Technology Services LLC (Buffalo, MN), entered into the accredited persons program this year, the first new arrivals in several years. 

For its part, UL, which says it is the most used of the 14 reviewers with 25% market share, is hoping to spur more interest in the program with a two-week money-back service delivery guarantee for devices that have a specific guidance document. UL says that if it does not complete the review in 10 business days after receiving all the required information, the manufacturer will pay nothing.

“We found that historically we had been able to turn these around in 10 days or less, and were saying so informally to prospective customers,” said Rudolph. “We hope that it spurs interest in the third-party program and brings manufacturers' attention to it. A lot of them still do not know that third parties can review some 510(k)s.”

He said the 10-day commitment can be honored because UL reviewers are not overwhelmed with too many projects, and can start reviewing a submission as soon as it is received.

For devices in the extended pilot program, the 10-day guarantee will not apply, but UL will negotiate specific timetables by which completion will be guaranteed. 

Whether because of faster review times, user fees, or UL's guarantee, even greater use of the third-party program is expected in the near future. UL, in fact, is training new reviewers in anticipation of a boost in interest. 

If that happens, it means industry has come to realize the benefits of the program that Rudolph, a former FDA official who helped establish the 
accredited persons program, has always known.

“FDA saves its own resources to deal with more difficult reviews. Manufacturers get their products on the market quicker. And users get the products they need quicker,” he said. “It's the American way.”

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