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This feature article discusses the industry’s reaction to the Food & Drug Administration’s (FDA) newly-released information on their medical software precertification program. The article notes that initial reactions are split regarding an important question – If the FDA has statutory authority to implement pre-certification. Aaron Josephson, a senior director at ML Strategies and former senior policy advisor at FDA’s device center, is among the industry sources quoted within the piece.
This Law360 “Expert Analysis” column, authored by Mintz Member and Chair of the Environmental Practice Jeff Porter, notes that amid the ongoing chaos of competing Clean Water Act judicial decisions and agency actions, it is clear that Congress should have taken necessary action.
This feature article discusses the top FDA-related issues that the medical device industry is keeping an eye on for the 2019 year. Among those top concerns are new regulations involving laboratory developed tests (LDTs), digital health apps and medical device cybersecurity, among others. Aaron Josephson, senior director at ML Strategies and a former senior policy advisor at FDA’s device center, is among the industry sources quoted.
This Law360 Expert Analysis column, authored by Mintz Member Peter Saparoff and Associate Joel Rothman, discusses several recent developments which highlight why foreign securities litigation is an ever-changing scenario where nothing is definite.
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