JD Supra

FDA Releases Guidances on Transition Plan for Devices Distributed Under Emergency Use Authorization (EUA) or Enforcement Policies During COVID-19

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to ...
JD Supra

FDA Holds Webinar on Draft Transition Plans for COVID-19 Related Medical Devices and Enhances 510(k) Submission Tracker

On February 22, 2022, the U.S. Food and Drug Administration (FDA) hosted a webinar on two draft guidance documents for the transition plans for medical devices commercialized pursuant to either ...
Becker's Hospital Review

FDA finalizes PHE transition plan for medical devices

With the COVID-19 public health emergency set to expire May 11, the FDA is preparing to prevent any supply disruptions to medical devices after three years of shortages partly spurred by the pandemic.
STAT

Medicare finalizes reimbursement rule for breakthrough medical devices

The Centers for Medicare and Medicaid Services has finalized its rule easing reimbursement for medical device makers. Called Transitional Coverage for Emerging Technologies, the program gives device ...