Recent Posts tagged as 'Medical Devices'
Blog Post
01/22/2018
By Jonathan A. Havens

Within the past few weeks, the U.S. Food and Drug Administration (FDA or the Agency) has, among other things:

Blog Post
10/25/2017
By Jonathan A. Havens

​Yesterday, the U.S. Food and Drug Administration (FDA or the Agency) took a number of steps to “advance medical device innovation and help patients gain faster access to beneficial technologies,” as characterized by FDA Commissioner Scott Gottlieb, M.D. More specifically, the Agency:

Blog Post
07/21/2017
By Jonathan A. Havens

Last week, the U.S. House of Representatives (the House) passed by voice vote the FDA Reauthorization Act of 2017 (FDARA or the Act). Introduced on May 16, 2017 by House Energy and Commerce Committee Chairman Greg Walden (R-Ore.), Ranking Member Frank Pallone (D-NJ), and Health Subcommittee Ranking Member Rep. Gene Green (D-TX), the Act would reauthorize four key U.S.

Blog Post
06/21/2017
By Jonathan A. Havens

On June 15, 2017, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Dr. Scott Gottlieb announced that the Agency is developing a new Digital Health Innovation Plan (the Plan), through which FDA hopes to encourage industry growth by providing more regulatory certainty to device developers. Gottlieb also indicated that the Agency will soon pilot a new, risk-based approach toward regulating digital health technologies.

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