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This article was originally published in The Gray Sheet

Executive Summary

FDA's Center for Devices and Radiological Health should publish monthly reports on product submission review times and agency compliance with statutory review time frames, the Health Industry Manufacturers Association says in a document called "Suggested Changes to the CDRH Product Review Process." Monthly publications of "product review times and CDRH's status in meeting statutory requirements" is one of a number of short-term management oversight initiatives FDA should take to improve "the productivity and predictability" of the product review process in FDA's office of device evaluation, HIMA says in the report, which was released April 23. Short-term projects "should be addressed in one year or less," HIMA says. Another short-term FDA project should be to require reviewers "to explain to their supervisors why it is necessary to ask the applicant multiple rounds of questions," the association suggests. "A predictable, effective review system...should include means whereby reviewers ask one comprehensive set of questions about the applicant's submission" that "will enable the reviewer to make a final decision," according to HIMA. In addition to suggesting improvements to management oversight of reviewers, HIMA suggests that FDA develop "uniform criteria" product approval "via appropriate due process." HIMA notes that the center should emphasize "closure" so that the criteria are developed "within a reasonable period of time." The association offers its assistance in organizing experts for this short-term effort. Also in the short term, FDA should exempt all Class I devices from 510(k) requirements. HIMA maintains that these "relatively simple" devices "should be subject only to notification...and self-certification by the manufacturer that they are substantially equivalent." The agency has said it is considering exempting additional products from 510(k)s but has not endorsed exempting all Class I devices ("The Gray Sheet," April 5, p. 5). During the next year, CDRH also should fulfill its long-stated goal to draft a guidance that addresses "the policy on the threshold requirements for submitting" 510(k)s for device modifications, premarket approval application supplements and investigational device exemption supplements. HIMA suggests that in lieu of making additional filings, firms could self-certify some modifications. CDRH also "should interpret the current regulations on the need to file new 510(k)s and PMA supplements to mean that changes that do not relate to the device itself, or that involve modifications that will not have a significant impact on safety or effectiveness, need not be the subject of an additional application." For example, HIMA says, "if a production line is moved from one plant to another, the proper regulatory activity should be an inspection, not a PMA supplement." In the long term, HIMA advises that the center amend current IDE and PMA regs to "narrow the situations in which IDE and PMA supplements are required." IDE supplements should not be required "for most changes made to a device while the subject of a clinical investigation," HIMA maintains. Other suggestions made by HIMA include: increasing the number of reviewers, while familiarizing them with existing device technologies through training sessions; providing "mechanisms for improving communications with manufacturers"; using "postmarketing tools," such as MDR, "to allow less rigorous premarket reviews"; consolidating the management information system"; and "defining the role of" the office of compliance and surveillance in the product approval process. HIMA also recommends that FDA move quickly to streamline the export process, noting that CDRH should "establish internal time deadlines for responding to export requests" and export certificates, "should rely more heavily on foreign government import provisions," and should establish an "all-purpose certificate" for exports. In the long term, HIMA suggests that the center "initiate legislation so that the ability to export is dependent on the discretion of the" importing country.

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