The United States Court of Appeals for the Fourth Circuit recently affirmed a West Virginia federal district court’s holding that a plaintiff’s common law tort claim was preempted by the 1976 Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”). Under the MDA, certain medical devices, known as Class III devices, are required to receive premarket approval from the Food and Drug Administration (“FDA”). The MDA also allows the FDA to condition a grant of premarket approval on a requirement that a device meet certain performance standards. The establishment of a performance standard is a formal process that requires publication in the Federal Register and providing interested parties with an opportunity to comment. The MDA expressly preempts state medical device regulations that are “different from, or in addition to, any [federal] requirement.”
Medical Devices
FTC Mobile App Enforcement: Mobile App’s Acne Treatment Claims Require 2 Clinical Studies
By Kelley Drye on
Posted in Medical Devices, Product Labeling & Marketing
Yesterday, the Federal Trade Commission (“FTC”) approved a final settlement with marketers of the “Acne Pwner” and “AcneApp” mobile applications (“apps”). This is the first FTC settlement targeting health claims by mobile app developers/marketers, but one of several FTC mobile app enforcement actions.
In the AcneApp case, the defendants claimed that their apps could treat…
FDA Notice Clarifies Past Federal Preemption Policy Statements
By Kelley Drye on
The Food and Drug Administration (“FDA”) recently completed an evaluation of the legal basis for federal preemption policy statements the agency has issued under the Federal Food, Drug & Cosmetic Act (“FDCA”) during the past 10 years. FDA initiated the review in response to a memorandum issued by President Obama in May 2009 which directed…
FDA to Host Public Workshop on Mobile Medical Apps Guidance
By Kelley Drye on
The FDA announced that it will host a public workshop on September 12th and 13th, 2011 to gather input on the agency’s recently issued draft guidance document, “Mobile Medical Applications.” The FDA issued the guidance last month to inform manufacturers, distributors, and other stakeholders about how the FDA intends to apply its medical…
Hold the Tweets: Why Marketers of Consumer Health Products Should Watch For FDA’s Policy on Social Media
By Kristi L. Wolff on
The Food and Drug Administration (FDA) is expected to issue guidance and possibly regulations regarding use of social media. These policies will only be enforceable on marketers of prescription drugs and restricted medical devices; however, industry can expect that the rationale and policy behind the guidance and regulations will apply across the board to consumer…
Can We Say That? A Practical Guide to Substantiating Claims for Food and Consumer Health Products
By Kelley Drye on
This Monograph, published by the Food and Drug Law Institute, is designed to assist lawyers, regulatory advisors and marketing professionals answer the question "Can we say that?" as they design and execute programs to promote consumer health products such as foods, dietary supplements, non-prescription drugs and medical devices, cosmetics and pet care products. It serves…
Settlement with Indoor Tanning Association Regarding Claims Characterizing Disease Risks for Tanning and Vitamin D Supplements
By Kelley Drye on
On May 19, 2010, the Federal Trade Commission (FTC) approved a final settlement order with the Indoor Tanning Association charging that the association exaggerated the health benefits of indoor tanning and misrepresented that indoor tanning increases the risk of skin cancer. The settlement bars the Association from making misrepresentations about the health and safety of indoor tanning and requires that future advertisements from the association that make health or safety claims be accompanied by clear and prominent disclosures about the risks of indoor tanning. The Indoor Tanning Association represents tanning facilities and suppliers of tanning equipment.
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