Zdrowie i gospodarka · 27/04/1999

FDA Releases Draft Guidance on Resolving Scientific Disputes Over Medical Devices

The Food and Drug Administration (FDA) has made available a draft guidance document outlining procedures for resolving scientific disputes related to the regulation of medical devices, as mandated by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The document aims to provide a framework for the FDA to effectively address disagreements with the regulated industry.