HealthIT Answers August 17, 2020
Industry Expert

By Stephen M. Hahn MD, Commissioner of Food and Drugs, and Anand Shah MD, Deputy Commissioner for Medical and Scientific Affairs, FDA

Americans may be surprised to learn that many 21st century medical products are still being manufactured using technologies commonly employed since the middle of the last century. These manufacturing platforms are not dynamic and can increase the risk of shortages, limit flexibility during an emergency, and contribute to the high cost of medical products. For the past several years, the U.S. Food and Drug Administration has sought to encourage and facilitate the adoption of “advanced manufacturing,” which refers to new and emerging approaches for the production of medical technologies.

Advanced manufacturing approaches are applicable to different medical product...

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