How do companies move away from making costly errors during FDA inspections? That’s the question Michael Drues, president at Vascular Sciences and an independent regulatory and quality consultant, ...
Jan 6 (Reuters) - The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed to support healthy lifestyles, issuing new guidance to ...
The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...
Updated book highlights significant changes medical device developers need to knowPHOENIXVILLE, Pa.--(BUSINESS WIRE)--Facet Life Sciences, a regulatory affairs and product development strategy partner ...
For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and pay the Food and Drug Admi ...
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