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Small Business › Medical Devices

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

Goodwin

Fundraising Strategies for Early-Stage Medtech Startups

Goodwin on

Investor interest in the medtech sector is strong. According to DealForma and JPMorgan, medtech companies raised $16.1 billion from 544 funding rounds, including $3.3 billion from 244 seed and Series A rounds, through the...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

Morgan Lewis

CARES Act Provisions Impact Drug, Device, and Food Manufacturers and Suppliers

Morgan Lewis on

The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9...more

McDermott Will & Schulte

COVID-19 Legal Developments for Health Services, Emergency Measures in the United Kingdom

McDermott Will & Schulte on

The UK government has introduced sweeping changes to the UK health legislation as it urgently prepares for the impact of the Coronavirus (COVID-19) pandemic, including increased admissions and demand for intensive care...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

Baker Donelson

OIG May 2018 Work Plan Update

Baker Donelson on

The OIG added seven new items to its Work Plan in the May 2018 update. Among the issues addressed are emergency preparedness, the impact of generics on Medicaid drug rebates, reviews of claims for Part B outpatient cardiac...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

Medical Device Manufacturer’s Association Comments on Senate Hearing

Knobbe Martens on

The Senate Committee on Small Business and Entrepreneurship held a meeting titled “An Examination of Changes to the U.S. Patent System and Impacts on America’s Small Businesses” on February 25, 2016. ...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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