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.

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...

The 21st Century Cures Act includes substantial changes to the FDA's regulation of medical devices.

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.

A high-profile FDA hearing sought to receive broad stakeholder input on draft guidance documents from 2014 and early 2015 that explain the agency's views on criteria for the regulation level of HCT/P.

This is especially true for companies marketing in the EU.

Tier 1 is called "File and Use" and establishes an abbreviated DOH review similar to the prior Level 1 30-day review previously utilized.

One of the challenges of policy making is that bills must go before the Congressional Budget Office (CBO).