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This article was originally published in The Gray Sheet

Executive Summary

FDA'S DEVICE MODIFICATION 510(K) POLICY should require premarket notification submissions only when the manufacturer "is uncertain about the possible impact [of the modification] on safety and effectiveness" or "has determined that safety or effectiveness of the device will be significantly altered" as a result of the changes being made, the Medical Device Manufacturers Association argues in a Feb. 11 letter to FDA's Center for Devices and Radiological Health. FDA's 510(k) procedural regulations state that 510(k)s are warranted for device modifications if they "significantly affect the safety or effectiveness of the device." MDMA believes that FDA currently is interpreting the regulation too broadly and is taking inappropriate enforcement actions against firms that fail to file 510(k)s for device modifications that do not have a substantial effect on safety and effectiveness. In turn, the stepped-up enforcement has prompted firms to submit numerous 510(k)s for modifications that should not require agency review, according to MDMA. MDMA proposes that FDA "encourage greater use by manufacturers of internal decision-making and documentation of substantial equivalence decisions to reduce unnecessary premarket notifications to the CDRH." Where the "manufacturer of a device which is to be changed or modified determines that safety or effectiveness are not significantly affected," FDA's device center should "encourage manufacturers to document these determinations and discourage needless notifications." The association maintains that "the number of [premarket] notifications to the FDA would be considerably lessened" if firms were entrusted with greater responsibility to determine when a 510(k) should be submitted. Such a policy "was recognized and recommended by the FDA in 1977" when 510(k) regulations were published, MDMA argues. Clarifying the 510(k) modification policy is one of several steps that MDMA's letter recommends for returning "predictability to the premarket notification process." MDMA was formed in December to represent the interests of smaller device firms. The MDMA letter follows up on a January meeting between MDMA officials and former Center for Devices and Radiological Health Acting Director Elizabeth Jacobson, who has returned to the post of CDRH deputy director for science following Bruce Burlington's move to the helm of CDRH on Feb. 22 ("The Gray Sheet" Feb. 8, p. 1). The association plans to reiterate its concerns to Burlington in a meeting scheduled for the week of Feb. 22. Other MDMA recommendations for streamlining the FDA process include exempting all Class I products from premarket notification requirements. While some devices already are exempted, 510(k) clearance is required for "a significant number" of Class I products that could be adequately regulated by general controls, MDMA says. Claudia Beville, a staffer of Chairman John Dingell's (D-Mich.) House Energy and Commerce oversight subcommittee, made a similar suggestion at an industry conference earlier this month ("The Gray Sheet" Feb. 8, p. 5). MDMA also suggests that FDA eliminate the practice of issuing "admonitions" stating that "a remedial action [such as a recall or safety alert] by a manufacturer which is acceptable to the FDA . . . cannot be accomplished until a premarket notification order has been issued." The association claims that "this procedure is confusing" and "produces unnecessary premarket notifications and discourages accomplishments of worthwhile objectives." Another MDMA recommendation is that "any request for additional information [on a 510(k) submission] from a CDRH reviewer should be accompanied by written rationale which has been reviewed and approved by supervisory personnel." MDMA argues that this would "help to assure a supportable need for and consistent application of such requests." The association also urges the development of "documents describing the desired data contents for major categories of classified devices." CDRH plans to develop a number of guidance documents for premarket submissions on different types of devices ("The Gray Sheet" Feb. 15, I&W-6).

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