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Medical Devices › Food and Drug Administration (FDA) › Small Business

Hogan Lovells

FDA updates medical device user fee guidance for small businesses, tightening some rules for reductions and waivers

Hogan Lovells on

On July 31, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance document “Medical Device User Fee Small Business Qualification and Determination,” which supersedes its previous guidance document dated...more

Mintz - ML Strategies

COVID-19 Insights Week In Review — April 8, 2020

Mintz - ML Strategies on

As the coronavirus pandemic spreads across the nation, your team at ML Strategies continues to monitor legislative and regulatory updates at the federal and state level. Each week, ML Strategies will provide weekly updates...more

Skadden, Arps, Slate, Meagher & Flom LLP

CARES Act Provides Much-Needed Stimulus for U.S. Businesses, Individuals

Skadden, Arps, Slate, Meagher & Flom LLP on

On March 27, 2020, Congress approved the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to provide financial assistance to individuals and businesses, which in aggregate greatly exceeds the financial package...more

McDermott Will & Schulte

21st Century Cures: A Closer Look

McDermott Will & Schulte on

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

Knobbe Martens

FDA Announces 2016 Medical Device Fees

Knobbe Martens on

The Food and Drug Administration (FDA) recently issued a notice announcing the fiscal year (FY) 2016 medical device user fees, which apply to, among other things, applications for medical device approval. The National Law...more

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