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Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

US flag with microscope

US NIH goes live with network for evaluating cancer screening tech

Feb. 28, 2024
By Mark McCarty
The U.S. National Institutes of Health reported the launch of a network for clinical trials that will examine the utility of cancer screening tools, which will start with a pilot study of multi-cancer detection (MCD) tests.
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Judge's gavel with US flag

New US PTO guide may spur more patent rejections for obviousness

Feb. 28, 2024
By Mark McCarty
The U.S. Patent and Trademark Office (PTO) has released a guidance to aid patent examiners in dealing with questions of obviousness in patent applications, but patent attorney Michael Borella told BioWorld that this new guidance could resurrect the law of unintended consequences. Borella, a partner in the Chicago office of McDonnell Boehnen Hulburt & Berghoff LLP, said the guidance might lead to more inappropriate rejections of patent claims for obviousness, and thus make the process of obtaining a clean patent more difficult, not less.
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VC, private equity firms drawing more scrutiny from US DOJ

Feb. 27, 2024
By Mark McCarty
The U.S. Department of Justice (DOJ) has released the metrics for prosecutions under the False Claims Act (FCA) for fiscal year 2023, ringing up recoveries of nearly $2.7 billion, the 15th consecutive year in which recoveries exceeded $2 billion.
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U.S. FDA headquarters

FDA eyes predetermined change control plans for sterilization

Feb. 27, 2024
By Mark McCarty
The U.S. FDA’s approach to predetermined change control plans (PCCP) for medical devices has been widely viewed through the lens of artificial intelligence software, but the potential scope of PCCP is much broader than merely evolutionary software and iterative device designs.
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Flag of Australia, sky background

MTAA wary of TGA draft audit framework for premarket applications

Feb. 26, 2024
By Mark McCarty
Australia’s Therapeutic Goods Administration (TGA) proposed in July 2023 to develop a framework for audits for premarket device applications, but the Medical Technology Association of Australia (MTAA) registered several concerns about the proposal.
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U.S. flag and money

US Congress still struggling with FY 2024 spending bills for FDA

Feb. 26, 2024
By Mark McCarty
In recent years, the U.S. Congress has come to rely unduly on continuing budget resolutions to fund government operations, and fiscal year 2024 is no exception. The current continuing resolution (CR) for the FDA budget is set to expire March 1, but there is concern that Congress will resort yet again to a CR to cover the balance of fiscal 2024, a predicament which suggests that the FDA’s appropriations may be flat relative to fiscal year 2023.
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FDA icons and doctor

FDA still undecided on the use of silicone in endotracheal tubes

Feb. 23, 2024
By Mark McCarty
The U.S. FDA issued an update to a previous advisory to doctors regarding the use of electromyogram endotracheal tubes made by Dublin-based Medtronic plc., but there is still some noise in the agency’s communications regarding this matter.
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Laptop displaying FDA logo

Med-tech industry concerned with FDA’s RWE draft guidance

Feb. 22, 2024
By Mark McCarty
The U.S. FDA’s December 2023 draft guidance for the use of real-world evidence (RWE) for medical devices drew comment from across the spectrum of stakeholders, but industry is demonstrably wary of the draft on several points. The Medical Device Manufacturers Association (MDMA) offered several pointed criticisms, including that the draft seems to suggest that a fit-for-purpose study might be nearly indistinguishable from a conventional clinical trial, which MDMA said violates the least burdensome principle.
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william maisel

Device safety maven Bill Maisel to leave FDA after 14 years

Feb. 21, 2024
By Mark McCarty

After nearly a decade and a half of service at the U.S. FDA, Bill Maisel will retire from the agency, taking with him a wealth of experience as both a physician and a regulator. The agency said Owen Faris, also a long-time member of the FDA staff, will take Maisel’s place as the director of the Office of Product Evaluation and Quality (OPEQ), but this is a temporary stint for Faris as the agency will conduct a search for Maisel’s replacement.


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U.S. FDA headquarters

FDA warns bad data coming from device testing labs in China, India

Feb. 21, 2024
By Mark McCarty
Third-party testing of medical devices is an established practice, but some testing labs are more reliable than others. The U.S. FDA has warned device manufacturers that some of these labs are turning out falsified data in connection with such testing, calling out labs located in China and India as unusually suspect sources of testing data.
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