This is the third installment of our year-in-review series covering major developments at FDA. While the previous two installments, which can be found here and here, pertain to FDA actions on drugs and biologics, this post will address developments related to “traditional” medical devices and diagnostics (i.e., not software devices).
The Center for Devices and Radiological Health (CDRH) has had a busy year in 2017, and its activities appear to be in line with the general FDA strategy described in our prior installments: greater access to novel treatments through more consistent and efficient premarket review processes. We have seen guidance this year establishing premarket threshold criteria to ensure that a particular review process is appropriate, as well as guidance that may help speed up premarket review. CDRH also made significant progress developing new pilot programs as part of the Case for Quality initiative by establishing ground-breaking pilot programs and regulatory pathways for new technologies such as next generation sequencing (NGS) tests. Continue Reading FDA 2017 Year in Review: Refining Medical Device Pathways and Introducing Pilot Programs to Promote Quality