Philip Braginsky

Tarter Krinsky & Drogin LLP

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Latest Posts › Medical Devices

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FDA Issues Guidance Related To CARES Act Amendments For Medical Device Manufacturers

The U.S. Food and Drug Administration (FDA) recently published new guidance (the Guidance) related to actual or potential medical device shortages during the COVID-19 pandemic The Guidance is meant to implement Section 506J...more

5/14/2020 / CARES Act , Coronavirus/COVID-19 , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry

FDA’s Safety And Performance Based Pathway Guidance Expands Abbreviated 510(k) For Certain Device Types

There are three types of Premarket Notification 510(k)s that may be submitted to the U.S. Food & Drug Administration (FDA): traditional, special and abbreviated. Under the recently finalized Safety and Performance Based...more

4/17/2019 / 510(k) RTA , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Pharmaceutical Industry

Patenting And The New FDA Guidance On 3-D Printing Of Medical Devices

The U.S. Food and Drug Administration (FDA) recently finalized its publication on additive manufacturing (commonly referred to as 3-D printing) for medical devices. According to FDA Commissioner Scott Gottlieb, the guidance...more

1/25/2018 / 3D Printing , Additive Manufacturing , Food and Drug Administration (FDA) , Medical Devices , Patents

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