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Medical Devices › Regulatory Oversight › Enforcement Actions

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

Sheppard Mullin Richter & Hampton LLP

What to Watch: WHOOP Warning Letter

Sheppard Mullin Richter & Hampton LLP on

On July 14, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a warning letter (the “Warning Letter”) to WHOOP, Inc. (“WHOOP”), rejecting WHOOP’s claim that its wearable “Blood Pressure Insights” product...more

Mintz

[Podcast] Health Law Diagnosed – Best Practices for Communicating with the FDA

Mintz on

In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA. Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more

Knobbe Martens

FDA Accuses Third Party Testing Labs of Falsifying Data

Knobbe Martens on

The Food and Drug Administration (FDA) recently issued General Correspondence Letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories “after discovering data that was falsified or otherwise...more

Gardner Law

Staying Prepared Amid FDA Changes

Gardner Law on

Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

McCarter & English, LLP

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

McCarter & English, LLP on

In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

A&O Shearman

SEC Announces Settled Insider Trading Action Against Former Director Of Investor Relations

A&O Shearman on

On February 22, 2022, the Securities and Exchange Commission (SEC) announced that John-Michael Havrilla, a former Director of Investor Relations of PAVmed Inc. (PAVmed), a medical device company, had agreed to settle claims...more

Searcy Denney Scarola Barnhart & Shipley

FDA Warns of Risk of Failure in Stryker STAR Ankle Replacement Devices

Searcy Denney Scarola Barnhart & Shipley on

The U.S. Food and Drug Administration (FDA) is warning patients and healthcare providers of a “higher than expected risk” of failure in Stryker Scandinavian Total Ankle Replacement (STAR) devices. According to the FDA, the...more

Mintz - Health Care Viewpoints

Telemedicine Platform Recalled Over Failure to Obtain Pre-Market Clearance or Approval from FDA

Mintz - Health Care Viewpoints on

On August 8, 2019, FDA issued a notice on its medical device recall database stating that a company called Opternative, Inc. had initiated a recall for the Visibly Online Refractive Vision Test, a software application offered...more

Thomas Fox - Compliance Evangelist

Numbers, Numbers, Numbers and FCPA Enforcement

Thomas Fox - Compliance Evangelist on

If I told you that the last seven batting titles were won by baseball players who were originally from Venezuela, would you immediately run down to ICE and claim that our national pastime had been overrun by Venezuelan...more

Hogan Lovells

FDA Enforcement Activities Update for FY 2016: CDRH Warning Letters Fall to 8-Year Low

Hogan Lovells on

The Food and Drug Administration (FDA) recently released statitistics regarding its enforcement actvities for FY 2016. Of note, the number of warning letters issued by the Center for Devices and Radiological Health (CDRH),...more

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