Mark McCarty

Industry sees US FDA’s predicates draft guidance as extralegal

Dec. 14, 2023

The U.S. FDA’s draft guidance for selection of a predicate device in 510(k) submissions is part of a larger effort to overhaul the 510(k) program, but industry’s response is that this draft guidance goes too far.

UK’s NICE sees limited role for thrombectomy in pulmonary embolism

Dec. 13, 2023

By Mark McCarty

The U.K. National Institute for Health and Care Excellence is not utterly opposed to the use of mechanical thrombectomy as a treatment for pulmonary embolism, but the agency believes that the outcomes data for high-risk patients are lacking.

AI could overwhelm ability of US FDA to keep up

Dec. 13, 2023

By Mark McCarty

Artificial intelligence has morphed from a buzzword referencing a popular curiosity to a series of national security and competitiveness considerations, which was reflected in the tone of a recent hearing in the U.S. House of Representatives.

US constitutionality of qui tam relator seen as ripe for legal challenge

Dec. 12, 2023

By Mark McCarty

The qui tam or whistleblower lawsuit under the U.S. False Claims Act (FCA) has driven a large volume of litigation against life science companies, but three Supreme Court justices expressed misgivings about the constitutionality of the qui tam relator in the Court’s hearing of Polansky. Should a fourth Supreme Court justice harbor similar misgivings, the matter could be ripe for a hearing at the Supreme Court with the possibility that the qui tam relator would then be declared unconstitutional.

Medical AI remains a high-risk product under updated AI Act

Dec. 12, 2023

By Mark McCarty

The European Union’s Artificial Intelligence Act (AI Act) is widely seen as a groundbreaking piece of legislative handiwork, but companies in the life sciences may see it as a groundbreaker with negative consequences. The latest edition of the AI Act continues to treat medical AI software as a high-risk product, which would make these products exceptionally expensive and burdensome to bring to market in the EU and convince some companies in the medical AI business to skip the European market altogether.

2023 FDLI Enforcement Conference

FDA facing a ‘somewhat unimaginable’ volume of applications for LDTs

Dec. 8, 2023

By Mark McCarty

The U.S. FDA’s draft rule for lab-developed tests (LDTs) has proven to be every bit as controversial as expected, although the controversy is only marginally about the workload that would come with rulemaking.

2023 FDLI Enforcement Conference

Post-pandemic inspection load an ongoing struggle for FDA

Dec. 7, 2023

By Mark McCarty

The COVID-19 pandemic took a huge bite out of the U.S. FDA’s ability to conduct inspections in a timely manner, but the FDA’s Douglas Stearn said the agency has nonetheless ramped up these activities.

2023 FDLI Enforcement Conference

FDA tells industry to get serious about UDI compliance

Dec. 7, 2023

By Mark McCarty

The unique device identifier (UDI) might not be the most exciting U.S. FDA enforcement mandate for most of regulated industry, but the FDA’s Keisha Thomas indicated that compliance is less than adequate in the agency’s view. Thomas addressed an audience at the Food and Drug Law Institute’s annual enforcement conference here in the nation’s capital, acknowledging that the proposed alignment of the Quality System Regulation – also known as Part 820 – with ISO 13485 is no light lift.

2023 FDLI Enforcement Conference

Abiomed warning letter for final deviation seen as opening salvo

Dec. 7, 2023

By Mark McCarty

The U.S. FDA’s recent warning letter to Danvers, Mass.-based Abiomed Inc., may have come across as an enforcement outlier in the context of the agency’s controversial final guidance for clinical decision support (CDS) products.

FDA approved icons and medical professional

2023 FDLI Enforcement Conference

FDA tells industry to get serious about UDI compliance

Dec. 6, 2023

By Mark McCarty

The unique device identifier (UDI) might not be the most exciting U.S. FDA enforcement mandate for most of regulated industry, but the FDA’s Keisha Thomas indicated that compliance is less than adequate in the agency’s view.