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Medical Devices › 21st Century Cures Act › Manufacturers

Orrick, Herrington & Sutcliffe LLP

Will FDA’s Warning Letter to WHOOP Put a Chill on Wearables?

Orrick, Herrington & Sutcliffe LLP on

FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying exponential growth in the health and wellness space. “Wellness technology”, a result of the...more

Lippes Mathias LLP

Medical Devices in the App Store? U.S. Regulation of Mobile Medical Applications

Lippes Mathias LLP on

Since the start of the COVID-19 pandemic, more people than ever have downloaded and used mobile applications, or apps, to communicate with their doctors, manage prescriptions, and streamline much of the healthcare activity...more

ArentFox Schiff

HOPPS and Physician Fee Schedule Proposed Rules: What Pharmaceutical and Device Manufacturers Need to Know

ArentFox Schiff on

CMS is soliciting comments on whether future payments for devices that may have been impacted by the COVID-19 PHE should be adjusted. The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related...more

Butler Snow LLP

Pro Te: Solutio Vol. 11 No. 1 – A Reflection on the First Ten Years

Butler Snow LLP on

It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Strives to Adapt Regulatory Approach to Rapidly Evolving Digital Health Space

Skadden, Arps, Slate, Meagher & Flom LLP on

Just two months after taking office, in July 2017, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced the agency’s Digital Health Innovation Action Plan, which recognized that “digital technology has...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

McDermott Will & Schulte

21st Century Cures: Examining Medical Device Provisions

McDermott Will & Schulte on

The 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment and facilitating innovation review and...more

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