No Time Like the Present: FDA Issues Numerous Device-Specific Guidance Documents in 2018 – 2nd Installment

By: Suzan Onel and Jacqueline Chan [1]

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”)[2] 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:

  • FDA will continue to foster greater use of real world evidence and will actively participate in the National Evaluation System for Health Technology (“NEST”).
  • FDA will continue to work on ways to modernize the 510(k) pathway for certain moderate risk devices. For example, the Center proposed a new approach for direct-to-consumer genetic health risk tests (“DTC GHRs”) that allows a sponsor of DTC GHRs to bypass review for new claims and modifications (with a few exceptions) once it has demonstrated through a cleared 510(k) submission that it competently validates tests and performs consumer comprehension studies well.
  • FDA plans to advance medical device cybersecurity through various means including, updating premarket guidance on medical device cybersecurity and considering new postmarketing authority to require firms to adopt policies and procedures for disclosure of vulnerabilities.
  • Finally, FDA is integrating CDRH’s Office of Device Evaluation with its Office of Compliance and Office of Surveillance and Biometrics to create a “super office” that uses the Total Product Life Cycle approach to device safety. The goal of this new organizational structure is to regulate more holistically by product type and facilitate greater communication and collaboration across offices.

[1] The authors gratefully acknowledge the contributions to this Alert by Dan Logan, KKB associate, and Celeste Wheeler, former KKB associate.

[2] Pub. L. No. 114-255 (2016).