CDRH Releases List of Guidance Documents Expected for 2017

CDRH released a list of final and draft guidances it intends to issue in fiscal year 2017.

Its top tier, the “A” list, includes 12 final guidances, two of which have already been released, and four draft guidances. It also published a “B” list of five additional final guidances and eight draft guidances it intends to release if resources permit.

The 10 final guidances on the “A” list still to be released include two key topics: use of real-world evidence to support regulatory decision-making and determining substantial equivalence in premarket notifications. The two final guidances already released are Postmarket Management of Cybersecurity in Medical Device and Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types. — Jeff Kinney