Third-party review offers haste not waste at FDA

Former agency official provides expert advice

Vendors in a hurry to get FDA clearance can cut review time in half by going through a third-party review, according to Underwriter Laboratories (UL), one of about a dozen companies to offer such services. Submissions sent directly to the FDA typically take 90 days for a 510(k) decision to be made. Those sent first to UL reviewers routinely get an answer in 45 days, said Harvey Rudolph, Ph.D., global program manager for medical at UL.

Virtually any device involved in modern diagnostic imaging can be reviewed by an FDA-approved third party such as UL, according to Rudolph. The only exceptions have to do with therapy and some obscure devices such as photofluorographs, which involve large fluorescent screens from which diagnoses are made.

"The reason companies come to a third party like UL is that we provide faster turnaround time," said Rudolph, a one-time FDA official.

While serving in the agency, Rudolph established its third-party review system. He is a natural for the job as UL point man for its third-party review service. Prior to joining the company in 2000, the 25-year FDA veteran worked on consensus standards for satisfying regulatory requirements and helped evolve the FDA's software policy. He has served on the ISO/IEC Joint Working Group for Risk Management and cochairs the U.S. Technical Advisory Group.

"On the third-party review program at UL, I help with the touchy questions," he said. "People frequently refer questions to me, and I'll get an answer quite quickly."

The expertise of Rudolph and his staff is not cheap, however. UL, which currently claims 25% market share for this service, charges between $5000 and $10,000 per submission. But vendors have to pay no matter which route they go. Currently, the user fee paid the FDA by manufacturers to review a device is $2189. Beginning Oct. 1, the fee will jump to $3400, which narrows the gap between the FDA and private enterprise.

For the extra money, UL guarantees customers that the review by UL will be completed within 10 business days for devices routinely covered by third-party review. Other devices that are technically covered but for which FDA has not developed a guidance document may take longer. For these, UL will negotiate a specific turnaround time. If the company fails to meet the agreed-upon turnaround, the manufacturer is refunded the fee. Once third-party review is done, UL sends its conclusions with the original submission to the FDA, which-as part of the third-party system-promises to render a final decision to the manufacturer within 30 days.

Not everything always goes smoothly, of course. A submission judged incomplete by UL, for example, will be delayed until the necessary information is provided. In such a case, UL reviewers "stop the clock" at the time they request additional information and restart it when the information is provided.

"Typically, a lack of information doesn't stop the clock," Rudolph said. "This happens only if the company has to generate information and it will take them some time to do so. We are saying 10 days of our working time."

A review stopped after three business days, for example, will have only seven more to be finished, once the requested information is in hand.

Time savings is only one advantage of the program Rudolph has crafted at UL. Manufacturers are guided through the process by UL reviewers who look for and identify deficiencies in the applications, when they first receive the 510(k).

"We have the same problems that FDA reviewers have," Rudolph said. "Nothing is ever routine."