Medical Device Legal News with Sam Bernstein: Episode 11
The Equal Employment Opportunity Commission (EEOC) has followed up on proposed regulations that it issued this spring on wellness programs under the Americans with Disabilities Act (ADA) with a new set of proposed regulations...more
On Jan. 16, 2015, the U.S. Food and Drug Administration promulgated a much-anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest attempt...more
On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much - anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest...more
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
On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “General Wellness: Policy for Low Risk Devices.” The draft guidance carves out a category of products, deemed “general...more
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