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Medical Devices Fees Manufacturers

Mintz - Health Care Viewpoints

FDA in Flux — August 2025 Newsletter

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more

Gardner Law

The Value of MDUFA

Gardner Law on

Anyone who has submitted a medical device for pre-market review knows the financial investment it takes to for FDA to conduct its review. Under the Medical Device User Fee Amendments (MDUFA), certain submissions, including...more

Hogan Lovells

OIG issues two unfavorable decisions, cautions against some customer service fees paid by manufacturers

Hogan Lovells on

The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued two unfavorable decisions in Advisory Opinions (AOs) 25-04 and 25-08 (the “Opinions”), finding that some service fees paid by...more

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