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De Novo Submissions– Bethany Hills, Chair, FDA Practice (Video)
Bethany Hills, Chair of Mintz Levin's FDA Practice, discusses the difference between a de novo submissions and 510k submissions, and the benefits of utilizing the de novo pathway.
United States
1 Dec 2017
Establishing And FDA Practice At Mintz Levin - Bethany Hills, Chair, FDA Practice (Video)
Bethany Hills, Chair of Mintz Levin's FDA practice explains why the firm's well-established Health Care, Mergers & Acquisitions, and Intellectual Property practices, coupled with the firm's work...
United States
29 Jun 2017
Future Of FDA Regulation Of Digital Health (Video)
The 21st Century Cures Act includes substantial changes to the FDA's regulation of medical devices.
United States
14 Jun 2017
Hospital Adverse Event Reporting System To Be Integrated Into FDA Nest Program
Based on recent FDA statements, it looks as though the FDA would like to integrate hospital medical device reporting obligations into the National Evaluation System for health Technology framework.
United States
9 Nov 2016
FDA Concludes Two-Day Public Hearing On Human Cell And Tissue Product (HCT/P) Regulatory Paradigm
A high-profile FDA hearing sought to receive broad stakeholder input on draft guidance documents from 2014 and early 2015 that explain the agency's views on criteria for the regulation level of HCT/P.
United States
20 Sep 2016
FDA Deep Dive: Real Life Implications Of FDA NEST Program Explored
This is especially true for companies marketing in the EU.
United States
22 Jul 2016
New York DOH Proposes Updated Provider Contract Guidelines
Tier 1 is called "File and Use" and establishes an abbreviated DOH review similar to the prior Level 1 30-day review previously utilized.
United States
22 Jun 2016
Research Opens A Door For Disability Policy
One of the challenges of policy making is that bills must go before the Congressional Budget Office (CBO).
United States
7 Jun 2016
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