FDA Issues Guidance for Low-Risk General Wellness Products

By | FDA Law Update | January 23, 2015
FDA Issues Guidance for Low-Risk General Wellness Products

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 medical devices under Section 201(h) of the Food Drug & Cosmetics Act (the “Act”) and are therefore subject to the Act’s regulatory requirements for devices.

The Changing Landscape for Services Contractors

The Changing Landscape for Services Contractors

Two recent developments have the potential to change the landscape for contractors providing services to the Government.  Government contractors and subcontractors are required to comply with a host of regulations governing their hiring practices and the wages they pay and benefits they provide to certain categories of employees.