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

European Commission Proposes Amending Transitional Provisions in Medical Devices and In Vitro Diagnostics Regulations

On 6 January 2023, the European Commission adopted a proposal to amend the transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro ...
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 ...
RAPS

CDRH FY 2021 guidance slate includes post-EUA transition plan

Surgical staplers and laparoscopic power morcellators are among devices that made the grade for the US Food and Drug Administration’s (FDA’s) slate of final guidance topics for fiscal year 2021. The ...
RAPS

Asia-Pacific Roundup: TGA posts guidance on transition to device reclassification after consultation confusion

Australia’s Therapeutic Goods Administration (TGA) has published guidance on the transitional arrangements for the reclassification of certain medical devices. The guidance follows a consultation that ...