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This article was originally published in The Gray Sheet

Executive Summary

FDA 510(K) "REFUSE TO ACCEPT" RATE OF 33% is lower than was expected under the new policy, according to Lillian Yin, director of the division of reproductive, abdominal, ear nose and throat, and radiological devices (DRAERD) at the device center's office of device evaluation. Addressing a July 20 Health Industry Manufacturers Association meeting on device submissions in Arlington, Virginia, Yin said that "one-third" of the premarket notification submissions "were turned down" since a pilot program for the "refuse to accept" policy was initiated in DRAERD on June 15 ("The Gray Sheet" June 21, p. 16). The device center initially anticipated that the rejection rate was "going to be" approximately 50%, Yin said. Yin noted that the "refuse to accept" rate would have increased to 40% if FDA had refused all applications that failed to include the 510(k) safety and effectiveness summary or statement that is required under the Safe Medical Device Act of 1990. Instead of refusing the 510(k)s that lacked this information, DRAERD informed manufacturers that their submissions would be reviewed upon FDA's receipt of the necessary documentation. The "refuse to accept" policies for 510(k) and investigational device exemption submissions were unveiled at a June 30 advisory panel chairpersons meeting ("The Gray Sheet" July 5, p. 5). Under the policy, FDA will return a submission to the manufacturer if it does not meet minimum criteria spelled out in reviewer checklists developed by ODE. The agency also revised its "refuse to file" program for premarket approval applications, making acceptance criteria for PMAs more stringent. The "refuse to accept" program was one of three FDA device evaluation reform initiatives discussed at the HIMA meeting. The other two efforts involve prioritizing review of devices based on risk ("triage") and expanding the expedited review policy (see related story, p. 1). David West, deputy director of ODE, announced that FDA "will be implementing the 'refuse to accept' and the 'refuse to file' and expedited review [programs] literally within weeks" throughout all of ODE. He added that the implementation would be done "in a very deliberate fashion," with ODE holding a two-day training session the week of July 26 at which all staff will "be walked through the philosophy, walked through the policies, and the criteria...and the checklists." In a July 21 session of the HIMA meeting, Yin was asked by Pamela Weagraff, a HIMA management fellow from Hewlett-Packard, if she could "give some sense of the types of things that were missing" from the 510(k) applications that DRAERD refused to accept. Yin responded that the division had not "delved into the detail yet," but that it is working to "tabulate that all very carefully." Mark Heller, a partner at Patton, Boggs and Blow in Washington, D.C. and former associate chief counsel for devices in the office of the general counsel at FDA, found the "refuse to accept" policy for 510(k)s "fairly troubling." Noting that there is statutory support for the refusal to file PMAs, Heller said that "there is no legal structure in the premarket notification side to support the policy." Heller also criticized the lack of a codified mechanism to appeal a nonfiling decision for a 510(k). He argued that it would be "in the FDA's and industry's best interest" to "formalize...a procedural regulation, so that people know the rules of the road and have a fair opportunity to raise questions about agency decisions that are detrimental to their companies." HIMA also reported the results of its model 510(k) project at the July 20 meeting. The project, which began in early 1992 ("The Gray Sheet" March 16, 1992, p. 7), was designed "to enhance learning" for manufacturers and ODE by "gaining 'real life' understanding of the 510(k) process in terms of preparation and review," according to Weagraff, who coordinated the program. The model 510(k) project evaluated ODE's review of two 510(k)s: a new product submission for a Class II cardiac catheterization recording system, and a modification for a Class II diagnostic ultrasound device. The reviewers of the 510(k)s were not aware that the submissions were being monitored. The cath lab device cleared in eight months, with a single round of questions to the manufacturer, while the diagnostic ultrasound device cleared in five months, also with a single round of questions. The discrepancy in review times illustrated that "divisions and branches may differ in total product approval workload and workload mix," Weagraff commented. Two of the major conclusions drawn from the project, listed in a document provided at the meeting, relate to the content of a 510(k). Manufacturers are alerted to "determine specific but comprehensive information to be included in the submission" to ensure that they establish equivalency to a predicate device. Sponsors also are advised to study all information available from FDA on 510(k)s before making a submission, including: 510(k) regs, the device center's "blue book" memos, guidance documents, voluntary standards, specific branch requirements and previous 510(k) applications. The results of the project also highlighted the importance of the format and presentation of a premarket notification submission. The HIMA document notes that the sponsor should "ensure that the reviewer can quickly locate information" and that the information can be easily read and understood. HIMA also stresses the importance of communication with the reviewer, and makes specific recommendations on when to contact the agency and who should be contacted regarding submission clarifications.

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