MD&M East

Practical Considerations for Draft Transition Plans for Devices Under EUAs or COVID Enforcement Policies

On Jan. 31, 2020, the Department of Health and Human Services (HHS) declared a public health emergency (PHE) related to the global COVID-19 pandemic. The declaration of a PHE enabled FDA to issue a ...
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On February 22, 2022, the U.S. Food and Drug Administration (FDA) hosted a webinar on two draft guidance documents for the transition plans for medical devices commercialized pursuant to either ...
JD Supra

The FDA Finalizes Transition Plan for Medical Device Authorizations and Policies Affected by Covid-19 PHE

The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance ...
Nasdaq

Wright Medical Group N.V. Announces Update to Medicare Transitional Device Pass-Through Payment for AUGMENT® Regenerative Solutions

AMSTERDAM, The Netherlands, July 20, 2020 (GLOBE NEWSWIRE) -- Wright Medical Group N.V. (NASDAQ: WMGI) today announced that the Centers for Medicare & Medicaid Services (CMS) published an update to ...