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Home » Authors » Mark McCarty

Articles by Mark McCarty

Science and medicine icons with head made of computer code

FDA to convene advisory meeting on generative AI-enabled devices

Sep. 16, 2024
By Mark McCarty
The Nov. 20-21 meeting of the digital health advisory committee will discuss the use of generative artificial intelligence algorithms in medical devices with a focus on the total product life cycle – a theme that suggests a concern on the agency’s part regarding the reliability of these algorithms’ output.
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WHO headquarters, Geneva

WHO leaning in on regulatory harmonization for devices

Sep. 16, 2024
By Mark McCarty
Hiiti Sillo, director of the WHO’s office for regulation and safety, told an audience at this year’s IMDRF meeting in Seattle that WHO is putting the finishing touches on a streamlined product application dossier process, one of several work products that should be ready for publication sometime in 2025.
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US flag, gavel, book

DOJ tracking device industry’s coverage and coding recommendations

Sep. 13, 2024
By Mark McCarty
The U.S. Department of Justice reported that THD America Inc., and its Italian corporate parent company agreed to pay $700,000 over inducing physicians to use incorrect payment codes in Medicare and Medicaid claims.
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3D map of China

FDA deals GLP warnings to 2 labs in China

Sep. 12, 2024
By Mark McCarty
The U.S. FDA issued warning letters to a pair of non-clinical testing labs located in China for violations of good laboratory practices, but the fall-out may reach existing marketing authorizations.
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U.S. FDA headquarters

FDA’s patient preference draft implicates product labeling

Sep. 11, 2024
By Mark McCarty
The FDA’s Sept. 5, 2024, draft guidance for the use of patient preference information (PPI) over the total product life cycle represents a new set of requirements for device makers when obtaining such information. Going forward, device makers may be required to provide more detail about patient heterogeneity, including when the benefit-risk calculation varies by subpopulation.
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Cyber eye illustration

EMA advises competent authorities to exercise caution in use of LLMs

Sep. 11, 2024
By Mark McCarty
The European Medicines Agency advised its member state regulatory partners to closely track how they use LLMs in making regulatory decisions – a clear signal that some regulatory decisions may be inappropriately torqued by their well-known shortcomings.
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De novo key on keyboard

Digital products lead FDA’s de novo parade for September

Sep. 10, 2024
By Mark McCarty
The U.S. FDA posted a series of de novo decisions Sept. 9, including a digital diagnostic for chronic kidney disease progression by Renalytix AI Inc., of New York, and a digital therapy device for management of fibromyalgia symptoms by Swing Therapeutics Inc., of San Francisco.
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Virtual IP display

FDA draws a fine line on disclosure for third-party servicers

Sep. 10, 2024
By Mark McCarty
The U.S. FDA’s final guidance for device remanufacturing was the result of a nearly decade-long policy examination, and the agency’s Sept. 10 webinar highlighted a few key questions. The FDA’s Angela Krueger said the agency “always encourages transparency” on the part of manufacturers to ensure device safety and performance but said the FDA does not endorse disclosure of trade secrets in providing information on device servicing.
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Gavel and vials

Delaware court hands J&J a $1B hit over Auris buy

Sep. 9, 2024
By Mark McCarty
A Delaware chancery court decreed that Johnson & Johnson Inc. owes investors in Auris Health Inc. more than $1 billion over allegations that J&J had undercut Auris products after the 2019 acquisition of Auris. The outcome highlights the hazards of acquisitions of companies that are competitive in a particular product space, but a shift in FDA policy regarding robotic surgical systems may have also played a role in this outcome.
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Cloud/cybersecurity illustration

CMS acknowledges 2023 cybersecurity hack of Medicare contractor

Sep. 9, 2024
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services posted a Sept. 6 statement regarding a cyber incident involving nearly 950,000 patient records held by a Medicare administrative contractor.
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