2018 has been notable for many reasons, not the least of which has been the flood of guidance documents FDA has issued related to medical devices. This KKB Alert highlights some of the most notable device guidances issued between January 1 and August 30, 2018, as they relate to (1) the implementation of legislative directives in the 21st Century Cures Act (“21CCA”) and the Food and Drug Administration Reauthorization Act of 2017 (“FDARA”), (2) the strategic priorities of the Center for Devices and Radiological Health (“CDRH”), (3) premarket submissions, and (4) postmarket responsibilities and activities. For ease of review, we will post our summary in four parts across four consecutive days to correspond with each of these topics.
II. Guidances Related to CDRH’s Strategic Plans and Priorities
FDA issued its vision for the future of CDRH in January 2018 in the document entitled, 2018-2020 Strategic Priorities. In April 2018, FDA supplemented this document with its Medical Device Safety Action Plan. Together, these documents reflect CDRH’s vision and strategies to reduce the time required to bring safe and effective devices to market while fostering innovation and improving device safety.
Notable elements are the following:
 The authors gratefully acknowledge the contributions to this Alert by Dan Logan, KKB associate, and Celeste Wheeler, former KKB associate.
 Pub. L. No. 114-255 (2016).