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Medical Devices › Wellness Programs

Mintz - Health Care Viewpoints

FDA Warning Letter Reminds Industry that Wellness Claims Only Go So Far, Other Features Can Establish Intended Use

Mintz - Health Care Viewpoints on

A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or overlooked merely because...more

Hogan Lovells

AI wellness or regulated medical device? A lawyer's guide to navigating FDA rules—and what could change next

Hogan Lovells on

As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that launch with the best of...more

Robins Kaplan LLP

The Tech Industry’s Next Frontier?

Robins Kaplan LLP on

Tongue-in-cheek references to Pokémon Go as a health App aside, maybe the tech industry is on to something. In the U.S., seven out of every ten deaths are due to chronic diseases, such as diabetes or heart disease. Perhaps...more

Stinson LLP

FDA Attempts to Clarify Enforcement Position Regarding Evolving Health Technology

Stinson LLP on

Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these...more

King & Spalding

FDA Issues Draft Guidance on Medical Device Accessories

King & Spalding on

On January 20, 2015, the U.S. Food and Drug Administration (FDA) issued a draft guidance document titled Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types (January 20, 2015)...more

Morrison & Foerster LLP

FDA Policy On Wellness Products Is Healthy For Industry

Morrison & Foerster LLP on

On Jan. 16, 2015, the U.S. Food and Drug Administration promulgated a much-anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest attempt...more

Morgan Lewis

Medical Device Update: FDA Releases General Wellness Products and Device Accessories Guidance Documents

Morgan Lewis on

Background - On January 20, 2015, the U.S. Food and Drug Administration (FDA or the Agency) announced the availability of two draft guidance documents in the Federal Register: “General Wellness: Policy for Low Risk...more

Morrison & Foerster LLP

Regulating a Healthy Lifestyle? FDA Distributes New Draft Guidance on “General Wellness Products”

Morrison & Foerster LLP on

On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much - anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Guidance for Low-Risk General Wellness Products

Sheppard Mullin Richter & Hampton LLP on

On January 20, 2015, the FDA issued draft guidelines designed to give developers whose products and applications promote healthy lifestyles (so-called “general wellness products”) direction on when such products qualify as...more

Akin Gump Strauss Hauer & Feld LLP

FDA Proposes Additional Flexibility for Mobile Health Products

Akin Gump Strauss Hauer & Feld LLP on

Draft Guidances Address General Wellness Products and Device Accessories - The U.S. Food and Drug Administration (FDA or “the Agency”) has announced two more key parameters of its regulatory approach to mobile health...more

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