Originally published September 1996
Seven companies have been selected to participate in FDA's pilot program for the third-party review of selected 510(k) premarket notifications. First proposed by FDA's Center for Devices and Radiological Health in April 1995, the program took nearly a year and a half to design and implement. Operation of the two-year program began on August 1.
The third-party review organizations appointed by FDA (see list on page 22) range from large independent testing labs to European Union (EU) notified bodies to small firms that were once primarily consulting firms. According to John Stigi, director of FDA's Division of Small Manufacturers Assistance (DSMA), the agency expects that the seven companies will be able to handle reviews for all the devices selected for inclusion in the program. Despite industry requests to broaden the range of eligible devices, FDA elected to include all Class I devices not exempt from 510(k) requirements, but only 29 Class II devices. After conducting their reviews the third parties will submit their recommendations to FDA, which has 30 days to render a final decision.
Speaking at the Biomedical Focus Conference and Exposition in Minneapolis in July, Stigi said that FDA received a total of 37 applications for the third-party review program, 28 of which were ultimately determined to be reviewable. In addition to the seven companies appointed, he said that another 15 or 16 probably would have been capable of managing reviews, but were weaker in some respects than those selected. "Many entities that submitted applications did not put their best foot forward, but our hands were tied by the information they actually submitted. We couldn't consider what we intuitively knew about the capabilities of an organization."
The primary determining factors for recognition, Stigi explained, were the qualifications of the third-party review personnel and their freedom from conflict of interest. The agency signaled early on that it considered conflicts of interest to be a major obstacle. The April 3, 1996, Federal Register notice calling for applicants described the most common conditions that would indicate a conflict of interest as:
* The third party being owned, operated, or controlled by a medical device manufacturer or distributor.
* The third party or any of its review staff having any ownership or other financial interest in a medical device manufacturer or distributor.
* The third party being involved in the design, manufacture, or distribution of any medical device.
* The third party consulting for any medical device manufacturer or distributor regarding any medical device.
* The third party participating in the preparation of any 510(k).
* A fee charged or accepted by the third party being contingent on the type of recommendation made by the third party.
In order to participate in the program, some of the recognized third parties had to modify their operations significantly. For instance, Nancy Sauer, president of RDD Consultants, Inc. (Louisville, CO), saw the decision to become a third-party reviewer as an either/or decision. "Either we continued as a consulting firm or we made the transition," she says. RDD Consultants has ceased all consulting and now focuses entirely on its duties as a third-party reviewer.
TÜV Product Service (New Brighton, MN) also terminated its medical device consulting activities. Gene Panger, director of sales and marketing for North America, explains that TÜV has also changed its policy on employee-owned stock to accommodate FDA. Employees whose job function is to review medical devices are no longer permitted to own stock in any medical device companies.
According to Peter Walker, scheme manager, Medical Devices Group, British Standards Institution Product Services (BSI; Milton Keynes, Buckinghamshire, UK) did not previously undertake consultancy, so there was no conflict of interest. However, the company will follow the guidelines described in Standards of Ethical Conduct for Employees of the Executive Branch, a final regulation issued by the U.S. Office of Government Ethics, in its device review operations. This document was provided by FDA as part of the information packet distributed to all potential third parties.
Another important element in selecting third-party reviewers was the type of expertise applicants demonstrated. According to Alfred Bracey, associate director of DSMA, FDA eliminated some applicants because they didn't have the expertise needed to review the devices they listed on their applications. Other companies were eliminated simply because their applications showed they could review only a limited number of devices. The agency also rejected any firm that could not communicate with it electronically by both modem and fax. During the program, FDA will not review applications from additional companies wishing to become third-party reviewers.
In order to offer the expertise needed to review 510(k)s, some of the third parties have forged partnerships with other firms. For example, CITECH (Plymouth Meeting, PA) shares a facility with ECRI, an organization that has performed testing and technology assessment for users of medical devices for over 20 years. "While CITECH is the FDA-recognized third-party reviewer," president Robert Mosenkis explains, "most of the detailed review activities will be done by ECRI." CITECH will act as the liaison between manufacturers and FDA.
Similarly, BSI has formed a partnership with the National Institute for Biological Standards and Control (Potters Bar, UK), which will handle the review of biological materials and diagnostic reagents.
It is unclear whether or not experience as a third-party reviewer in other coun- tries weighed in an applicant's favor during the selection process. Two of the FDA-recognized third parties act as third parties in other countries. BSI is an EU notified body under most European Council directives, including the Medical Devices Directive and the Active Implantable Medical Devices Directive. TÜV is also registered as an EU notified body for these same directives and recognized as an in-country caretaker in Japan. Sales and marketing director Panger sees the firm's new role as a third-party reviewer as complementary to its existing international roles. "TÜV can now offer market access services for Europe, Japan, and the United States," he explains. "Our overseas clients will view us as an alternate route to getting FDA clearance."
Another third-party reviewer that has had experience in reviewing medical devices is the California Department of Health Services (Sacramento), the only public agency recognized as a third-party reviewer. Prior to enactment of the Medical Device Amendments of 1976, the department had a device approval program under state legislation passed in 1963. After FDA took over the regulation of devices, the department focused on inspecting and licensing medical device manufacturing facilities in California and on its role in protecting public health. According to James Barquest, acting chief, Medical Device Safety Section, the department still retained statutory authority to review and approve medical devices, but did not continue such activities because it became necessary for manufacturers to obtain federal approval to market their devices. The department will now accept 510(k) submissions only from California companies.
When the two-year pilot program is completed, FDA will measure its success a number of ways. The Federal Register notice described a successful program as one offering device manufacturers an "alternative review process that can yield more rapid 510(k) decisions." DSMA's Bracey adds that FDA will also look at whether the program has "significantly reduced the workload of FDA reviewers." In the end, Bracey says, continuation of the third-party reviewer program will depend heavily on whether "manufacturers make use of it."
At the Biomedical Focus conference, Stigi was asked whether he believed the device industry would ultimately find the program useful. In response, he noted that FDA review times for 510(k) notifications have been falling throughout the past year, and are currently running at just over 100 days. Some third parties have said they will complete their reviews in 45 days or less, but they are not required to meet any deadlines, Stigi added. On the other hand, FDA's goal is to render decisions on completed applications within 30 days. "That would give manufacturers a total of 75 days, compared to the 100 days FDA is currently taking for the review," he said. "Considering that manufacturers will have to pay for a third-party review, it remains to be seen whether they will consider the gain of 25 days worth the added expense."
Leonard Frier, president of MET Laboratories (Baltimore), believes that the program can benefit both industry and FDA. "FDA can spend more of its time reviewing PMAs [premarket approvals], IDEs [investigational device exemptions], and Class III devices, and thereby reduce its backlog," he says. "In the past, it has been extremely expensive for manufacturers to develop a product and then have to wait because of this backlog. Now there is a solution."
And, argues RDD's Sauer, some third parties do guarantee speed. Her firm, for instance, plans to guarantee complete reviews of in vitro diagnostic products in 35 days or less. Frier anticipates that most reviews will take about 30 days, unless there are complications with the submissions.
Whether the pilot program is a success or failure, the process for reviewing medical devices will certainly be different in two years. If the program fails to interest device manufacturers, FDA could argue that its way of conducting reviews is the only viable method for the United States. If the program succeeds in attracting some manufactur- ers, FDA could characterize the payment of fees to third parties as justification for FDA user fees. And, if dozens of manufacturers choose to send their 510(k) notifications to third parties, we may see the beginning of a new third-party review system in the United States.--Daphne Allen