April 19, 2018

FDA Releases Medical Device Safety Action Plan

The Food and Drug Administration (FDA) released the “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” on April 17, 2018. The document discusses ongoing and planned initiatives to enhance, modernize and simplify the FDA’s regulatory oversight of medical devices with a focus on the following five areas:

  1. Establishing a robust medical device patient safety net;
  2. Exploring regulatory options to streamline and modernize timely implementation of post-market mitigations;
  3. Spurring innovation towards safer medical devices;
  4. Advancing medical device cybersecurity; and
  5. Integrating the Center for Devices and Radiological Health’s pre-market and post-market activities to advance the use of a “total product life cycle” approach to device safety.

The plan discusses several ongoing efforts to streamline FDA’s processes including the recent release of a draft guidance that would allow “well-understood” medical devices to be compared against performance criteria, as opposed to a predicate device, when demonstrating substantial equivalence for certain 510(k) submissions. The FDA is requesting input from public stakeholders on the draft guidance as well as the encompassment of well-understood device types and possible performance criteria that could be leveraged for these purposes.

American College for Radiology (ACR) members interested in providing feedback on FDA policies and initiatives should contact Michael Peters, ACR Director of Regulatory and Legislative Affairs, at mpeters@acr.org.