CDRH Releases FY2018 Proposed Guidance Documents

By MedTech Intelligence Staff

Priorities include unique device identification and next-generation sequencing for in vitro diagnostics.

Last week CDRH posted a list of the guidance documents it plans to issue in FY 2018. Prioritized by an A and B list, final guidance priorities include a UDI policy regarding compliance dates of Class I and unclassified devices, and appropriate use of voluntary consensus standards in premarket submissions for medical devices.

Draft guidance priorities include export certificates, the HDE and 510(k) third party review program, multifunctional device products, and least burdensome provisions.

Included on the B-list of final guidance topics is human factors list of high priority devices, and the draft guidance topics include premarket submissions for patient matched guides to orthopedic implants.

CDRH also lists several final guidance documents from 1978, 1988, 1998, 2008 that are subject to focused retrospective review by the agency.

The full list is available on the agency’s website.

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