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Michele Buenafe

Morgan Lewis

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FDA Proposes Framework for Transitioning COVID-Related Medical Devices from EUA/Enforcement Discretion to Permanent Marketing...

In two draft companion guidance documents, the US Food and Drug Administration (FDA) establishes a proposed framework for transitioning medical devices currently marketed under emergency use authorization (EUA) or enforcement...more

1/19/2022  /  Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Medical Supplies , Pharmaceutical Industry

UPDATE: Trump Administration’s Midnight Rulemaking to Exempt Certain Class I and II Devices from 510(k) Requirement Rescinded

In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS...more

4/26/2021  /  510(k) RTA , Biden Administration , Department of Health and Human Services (HHS) , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Regulatory Reform , Trump Administration

FDA’s End-of-Year Gifts: COVID-19 Diagnostic Tests and Collection Devices for Home Use

The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC...more

12/30/2020  /  Coronavirus/COVID-19 , Diagnostic Tests , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Infectious Diseases , Life Sciences , Medical Devices , Over The Counter Drugs (OTC) , Pharmaceutical Industry , Public Health Emergency

Inspections Remain on Hold; FDA Collaborates with CDC to Develop a Process to Resume Program

Life science companies should consider offering FDA creative solutions for submissions that require pre-approval inspections....more

5/29/2020  /  FDA Approval , Food and Drug Administration (FDA) , Inspections , Life Sciences , Pharmaceutical Industry

COVID-19: Transforming Your Manufacturing Operations to Supply Critical-Need Medical Devices

The White House is reportedly in discussions with US auto companies to aid in the coronavirus (COVID-19) relief effort by producing ventilators, and some US distilleries have already switched manufacturing operations to make...more

3/22/2020  /  Coronavirus/COVID-19 , FDA Approval , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Supplies , New Guidance

Recent FDA Medical Device Developments in Response to COVID-19

The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more

3/13/2020  /  China , Clinical Laboratory Testing , Coronavirus/COVID-19 , Crisis Management , Diagnostic Tests , FDA Approval , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Infectious Diseases , Inspections , Life Sciences , Marketing , Medical Devices , New Guidance , Personal Protective Equipment , Pharmaceutical Distribution , Pharmaceutical Industry , Premarket Approval Applications , Public Health , Supply Chain , Warning Letters

FDA Launches eSTAR Pilot Program to Further Simplify Medical Device 510(k) Submissions

In what appears to be another electronic tool in the US Food and Drug Administration’s quest to move to full digital submissions for medical devices, the eSTAR program provides 510(k) applicants with a PDF template document...more

3/12/2020  /  510(k) RTA , Automation Systems , CDRH , Electronic Filing , FDA Approval , Federal Pilot Programs , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry
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