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Home » Authors » Mark McCarty

Articles by Mark McCarty

U.S. FDA headquarters

FDA wary of overreporting of clinical study protocol deviations

Dec. 31, 2024
By Mark McCarty
The U.S. FDA’s draft guidance for reporting of deviations from clinical study protocols lends some insight as to the definition of a deviation, but the agency highlights some concerns about related compliance activities.
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AI biotech research concept with lightbulb and digital background
Year in review

Regulatory developments for AI gained momentum in 2024

Dec. 30, 2024
By Mark McCarty
Artificial intelligence (AI) is no novelty for medical technology, but 2024 saw an interesting series of events in this area from across the globe. While some of these developments portend immediate regulatory clarity, some are harbingers of continued regulatory flux in 2025 and beyond.
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Magnifying glass atop paperwork

FDA recounts problems with CDS, but no denominator offered

Dec. 30, 2024
By Mark McCarty
The U.S. FDA has issued a second report in connection with device software functions, which includes surveillance data for clinical decision support (CDS) tools. While the report lists three events that qualify as adverse events, the FDA offered no information that would provide an adverse event rate for CDS products.
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Gears with regulatory words
End of Year

2025 the year device makers need to rework quality management system

Dec. 27, 2024
By Mark McCarty
Device makers doing business in the U.S. have had a much more stable regulatory regime than has been true for companies in other jurisdictions, but that will shift somewhat in 2025. Brynn Stanley of Gardner Law told BioWorld that manufacturers should get busy with the U.S. FDA-mandated do-over of their quality management systems as the compliance deadline of February 2026 does not generally permit procrastination.
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Illustration demonstrating data flow from patient to doctor
End of Year

Firms may still be wary of responding to misinformation in 2025

Dec. 24, 2024
By Mark McCarty
The U.S. FDA’s newest draft guidance for dealing with medical product misinformation might seem to signal a cooperative attitude toward misinformation on the agency’s part, but regulatory attorney Daniel Kracov told BioWorld that the disincentives for doing so might still outweigh the incentives despite the reworked draft guidance.
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Hand holding FDA blocks

​FDA releases second advisory under early alert program​

Dec. 23, 2024
By Mark McCarty
The U.S. FDA posted another early advisory, this time for the Mini PCNL devices by Trokamed GmbH. The agency noted that these devices should not be used for suction and irrigation of surgical sites, a use for which the device was not cleared in the first place.
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Judge's gavel with US flag
End of Year

FDA likely to see more legal challenges to rulemaking, guidance in 2025

Dec. 23, 2024
By Mark McCarty
The U.S. FDA’s authority was challenged on a number of occasions over the past few decades, but the rate is likely to pick up as the U.S. Supreme Court ruled recently that the agency cannot take judicial deference for granted any longer. Chad Landmon of the D.C. office of Polsinelli told BioWorld that future litigation against the FDA may extend even to sub-regulatory guidance thanks to the outcome in the case of Loper Bright – a scenario in which industry might carve out a few significant wins in the coming year.
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FDA website and logo

FDA pushing standards to move away from ethylene oxide

Dec. 13, 2024
By Mark McCarty
The U.S. FDA’s emphasis on alternatives to ethylene oxide is gaining momentum with the help of internationally recognized standards — such as ISO 11737 — in a move that will enable a less cumbersome approach to non-EtO device sterilization.
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Gavel and FTC logo

Dual US antitrust enforcement likely to come under pressure in 2025

Dec. 12, 2024
By Mark McCarty
The fact that both the U.S. Federal Trade Commission and the Department of Justice have oversight of mergers and acquisitions is something of a regulatory oddity. But David Balto, an attorney specializing on antitrust matters, told BioWorld that this may change in 2025 thanks to support for such a move from both Congress and the White House.
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Cardiomems device with dime for scale

Cardiologists wary of CMS proposal for coverage of Cardiomems

Dec. 11, 2024
By Mark McCarty
Administrators at the U.S. Medicare program have proposed to cover the Cardiomems remote monitoring device for heart failure, but cardiologists are averse to several of the conditions spelled out in the draft coverage memo, including what they see as a somewhat futile demand for a comparator arm in the proposed coverage study.
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