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Medical Devices › FDA Warning Letters › 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

Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

Arnall Golden Gregory LLP on

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more

Gardner Law

FDA Issues Numerous Warning Letters

Gardner Law on

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Arnall Golden Gregory LLP

[Webinar] FDA Enforcement in the Product Promotion and Advertising World: (A Little Late 2021) Year in Review and Issues to...

Arnall Golden Gregory LLP on

Please join AGG Food & Drug attorneys Alan G. Minsk and Laura S. Dona for a complimentary webinar reviewing past FDA letters issued to pharmaceutical and medical device companies for unlawful promotion in 2021 and where FDA...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

Akin Gump Strauss Hauer & Feld LLP

Checking In On FDA’s Enforcement Discretion Policy for Laboratory Developed Tests

Akin Gump Strauss Hauer & Feld LLP on

• In a recent warning letter, the Food and Drug Administration (FDA) advised a laboratory to seek marketing authorization for its genetic tests that qualified as laboratory developed tests (LDTs)—which have largely benefited...more

Mintz - Health Care Viewpoints

Update on FDA’s Comprehensive Regenerative Medicine Policies and Enforcement Activities

Mintz - Health Care Viewpoints on

Since our 2018 year-end post on the busy FDA regulatory agenda, we are nearing the halfway mark of the “grace period” the Agency has extended for certain regenerative medicine product developers to come into compliance by...more

Akin Gump Strauss Hauer & Feld LLP

A Client’s Guide to FDA Recalls

Akin Gump Strauss Hauer & Feld LLP on

Recent FDA Recall Highlights & Developments - • The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more

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