News & Analysis as of

Wellness Programs › Medical Device Accessories

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Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate.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FDA Issues Draft Guidance on Medical Device Accessories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On January 20, 2015, the U.S. Food and Drug Administration (FDA) issued a draft guidance document titled Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types (January 20, 2015)...more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On Jan. 16, 2015, the U.S. Food and Drug Administration promulgated a much-anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest attempt...more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- On January 20, 2015, the U.S. Food and Drug Administration (FDA or the Agency) announced the availability of two draft guidance documents in the Federal Register: “General Wellness: Policy for Low Risk...more

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