Accredited third-party reviewers will be allowed to evaluate 510(k)s in a medical specialty area for which they have not processed applications before under the Center for Devices and Radiological Health's Feb. 2 final guidance on third-party review.

In making this allowance, FDA drops a requirement from its June 2000 draft guidance that blocked third parties from reviewing 510(k)s on its pilot list without having previously reviewed a device from the same specialty area (¹ Also see "FDA Pilots Expansion Of Third-Party Review To Devices Without Guidance" - Medtech Insight, 19 June, 2000.).

Under the draft document, a third party reviewing a 510(k) for a device that did not have a device-specific guidance - a cardiovascular product, for example - would need to have reviewed at least one Class II or Class I device in a similar medical specialty area.

The final guidance requires only that a third party contact the relevant CDRH Office of Device Evaluation branch prior to reviewing a product that is not similar to any reviewed before.

With the publication of the final guidance on the pilot, third parties may review Class II devices for which no device-specific FDA guidance exists. The pilot adds roughly 460 additional device classification codes to those under the existing third-party program. However, 510(k) submissions with clinical data remain off limits from review by third parties.

The June 2000 draft guidance automatically added 60 Class II and non-exempt Class I devices to the list eligible for review. Since then, FDA notes that it has received only one 510(k) submission from that list.

However, the agency has seen an increase in third-party submissions. Staffers estimate the agency has been receiving eight to 10 third-party submissions per month since the beginning of FY 2001 (Oct. 1), compared with two to three per month in FY 2000.

The FDA Modernization Act of 1997 created the third- party program, which allows accredited persons to conduct 510(k) reviews for Class I and certain Class II devices. Excluded from third-party review are Class III or Class II devices intended to be permanently implantable or life-sustaining or that require clinical data.

Previously, the third-party program allowed only Class II devices for which device-specific guidance or recognized standards existed to be reviewed. That list, expanded from 154 to approximately 211 devices last June, is more than doubled by the number of devices eligible under the new pilot.

The final guidance retains some of the stipulations from the draft guidance for participation in the pilot. Third parties must have completed three "successful" 510(k) reviews under the original third-party program before taking on a review from the expanded list.

Once it has contacted the relevant ODE branch chief, a third party may proceed with conducting a review of a 510(k) under the pilot. The third party must complete and submit a summary of its interaction with the office, but the documentation does not need prior review.

Although comments on the draft guidance that were submitted to CDRH complained that the documentation requirements would delay the review process, FDA staffers claimed they would not interfere with 510(k) submissions (² [A#01260370002]).

FDA attempted to minimize industry confusion by clarifying in the final guidance that the agency does not require the summary to be submitted before the 510(k) review. Instead, it must be submitted concurrently with the review.

The final guidance claims that the "pre-submission discussions and the creation of a record of those discussions will help FDA ensure the consistency and timeliness of reviews in the absence of device-specific guidelines."

Currently, seven groups have completed the requisite three reviews. These include the California Department of Health Services, CITECH, Intertek Testing Services, TUV Product Services, TUV Rheinland of North America, Inc., Underwriters Laboratories and Entela, Inc.

Two other third parties, N.V. Kema of the Netherlands and Taiwan's Center for Measurement Standards/ITRI, have completed at least one successful 510(k) review.

Comments submitted by the device trade association AdvaMed asked that the pilot expand to include 27 devices in the cardiovascular, gastroenterology and immunology area. These devices were not added in the final guidance because they are excluded by statutory criteria, according to CDRH.

Another area of debate remains the exclusion from third-party review of Class II devices requiring clinical data. FDAMA stipulates that in any given year there is a 6% limit on the number of Class II 510(k) submissions that can be excluded from third-party review due solely to the clinical data limitation.

In comments, the National Electrical Manufacturers Association said it was "surprised" that the draft guidance prohibited "any Class II devices requiring clinical data from inclusion from the program without offering a factual basis for the assurance that the number of such 510(k)s was under the 6% threshold."

The final guidance softened the language limiting third-party review of Class IIs requiring clinical data, noting that devices would be excluded "subject to limitations of the law," which allows for devices exceeding the 6% threshold to be considered.

FDA identified 56 Class II devices in FY 1999 that required clinical data and were thus not eligible for third-party review. The amount did not exceed the 6% threshold, however.

Under FDAMA, HHS is required to report to Congress within three years of the date of enactment to determine whether the clause excluding Class IIs that require clinical data should be removed.

A November 2000 HHS report to the Senate HELP Committee recommended Congress delay a decision on removing the exclusion clause until 2001, when FDA would be able to "assess the interest and capability of accredited persons to review 510(k) submissions."

The document also notes that a year-long review period would "give all stakeholders a chance to evaluate the interest of the industry in using third parties."

Responding to criticism that the 12-month review of the pilot was too short, FDA has expanded the evaluation to 24 months to "see if the number of third party reviews of 510(k)s increases significantly, if the timeliness of review is maintained, and if particular divisions within CDRH's Office of Device Evaluation are spending more staff time than expected in pre-submission discussions with accredited persons," the document explains.

However, the lengthier review time means the pilot will not be complete prior to a mandated review of FDAMA in November 2002.

In addition to devices for which device-specific guidance does not exist, the program extends to 510(k)-exempt devices that require 510(k) submission because they exceed the limitations of their exemption.

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