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FDA's Device Center Publishes 2017 Priorities for Guidances

NEW YORK (GenomeWeb) – The US Food and Drug Administration's device division has put out a list of guidance documents it intends to publish in 2017, among which include guidelines that would clarify regulations for garnering premarket approval or clearance of devices and diagnostics, particularly next-generation sequencing tests.

Next year, the Center for Devices and Radiological Health (CDRH) has put on its top priority, or "A" list, final guidances that outline the benefit-risk factors sponsors should consider when establishing substantial equivalence for 510(k) clearance for tests with different technological characteristics. Additionally, it details (as instructed by the 21st Century Cures Act) the use of real-world evidence in regulating medical devices, and goes over new or revised procedural policies for medical device user-fee discussions.

This year, the agency released two draft guidances on NGS-based diagnostics ― one that focused on establishing analytical validity standards for germline disease testing and another that discussed the use of public genetic variant databases to support the clinical validity of such tests. The agency has gathered public input on these document through the Federal Register and through public meetings, and hopes to finalize them in the coming year. Additionally, the FDA has prioritized a final guidance on infectious disease NGS diagnostics for microbial identification and detection of antimicrobial resistance markers.

FDA's "A" list for 2017 draft guidances include topics such as investigational device exemption, CLIA waivers, and MDUFA implementation. On its "B" list ― which include guidelines the agency would like to address if resources allow ―are those that would detail how sponsors should evaluate and report age, race, and ethnicity data as part of medical devices studies, and how the FDA categorization of investigational device exemption devices can help the Centers for Medicare & Medicaid Services with its coverage determinations.

Finally, the FDA has published a list of final guidance documents it issued in 2007, 1997, 1987, and 1977 and that it is considering reviewing in order to assess which of them should be revised or withdrawn. The aim is to make sure that previously issued guidances remain current, and the CDRH plans to publish such lists annually through fiscal year 2025, so that "FDA and stakeholders will have assessed the applicability of all guidances older than 10 years."

The agency is seeking stakeholder feedback on its 2017 guidance priority list in the Federal Register.