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On February 22, 2022, the U.S. Food and Drug Administration (FDA) hosted a webinar on two draft guidance documents for the transition plans for medical devices commercialized pursuant to either ...