PMA Parallels
This article was originally published in The Gray Sheet
Executive Summary
Harvard cardiologist and device safety expert William Maisel sees a parallel "loophole" in FDA's model for assessing modifications to existing PMA products, which he says allows too many products on the market by means of a PMA supplement, which is less rigorous than a full PMA application.
You may also be interested in...
PMA Supplement Guidance Finally Finalized, But Questions Remain
FDA finalized guidelines Dec. 11 explaining what PMA supplement submissions are required for certain product modifications, largely mirroring 2007 draft guidance that device makers considered "incomplete.
EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions
It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.
How Ochre Bio Bagged Boehringer For Its RNA-Based Regenerative MASH Therapies
UK-based Ochre Bio has signed its first major deal with Boehringer Ingelheim. Scrip talked to its co-founder and CEO, Jack O’Meara, about its human tissue-based drug discovery platform, its resulting RNA platform for liver disease and how the fledgling drug company's early work mirrored that seen in diagnostics.