HRS Comments on FDA’s 2020 Guidance Priorities

November 13, 2019 – The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has released its final and draft guidance publication priorities for the 2020 fiscal year.

The Heart Rhythm Society submitted comments on (1) the inclusion of the development of a draft guidance document titled Content of Premarket Submissions for Management of Cybersecurity in Medical Devices as a Category A document; and (2) the necessity for an update of the 1990 document titled Implantable Pacemaker Testing Guidance.