News & Analysis as of

Centers for Medicare & Medicaid Services (CMS) Premarket Approval Applications

Mintz - Health Care Viewpoints

FDA Introducing a Variety of Programs to Help Medical Devices Get to Market

Over the past couple of years, FDA has introduced multiple programs allowing faster review of medical devices in order to get them to market more quickly. Some of the FDA’s efforts have been highly visible, such as the...more

Mintz

Medical Device Updates: U.S. Food and Drug Administration (FDA) Practice Trends

Mintz on

Data and Analytics — FDA’s Post-market Surveillance Data Proposals Press Forward - FDA’s National Evaluation System for Health Technology, or NEST, as FDA calls it, is quickly gaining traction as one of the...more

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