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Home » Authors » Mark McCarty

Articles by Mark McCarty

Woman scanning test tubes in the lab

Skepticism greets US FDA’s ramp-up of IVD reclassification program

Feb. 2, 2024
By Mark McCarty
The U.S. FDA has announced the next stage in its program to down-classify a series of in vitro diagnostics (IVDs) from class III to class II, a change that would significantly ease the premarket requirements for these test types. Much of the emphasis here is on companion diagnostic (CDx) tests, a category of products that is the focus of a separate FDA imperative, but there are those who view this down-classification regime as little more than a meager attempt to paste over a massive impending regulatory overhang.
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Gavel and FTC logo

Amgen-Horizon deal blasted as an example of FTC’s delaying tactics

Feb. 1, 2024
By Mark McCarty
The U.S. Federal Trade Commission (FTC) has drawn blistering criticism over the past couple of years over its handling of merger and acquisition (M&A) activity, criticism that was anything but blunted in a Jan. 31 webinar on the subject.
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U.S. at night from space with circuit board overlay

FDA staff can access management meeting notes in QMSR final rule

Jan. 31, 2024
By Mark McCarty
The U.S. FDA dropped the final rule for the Quality Management System Regulation (QMSR), the long-awaited blending of the agency’s own Quality System Regulation (QSR) and ISO 13485.
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Toy bulldozer moving FDA letter blocks

FDA’s real-world evidence draft expands data requirements

Jan. 30, 2024
By Mark McCarty
The U.S. FDA’s latest draft guidance for the use of real-world evidence (RWE) is a substantially heftier document than the 2017 final guidance that will shortly become obsolete, and buried in all those extra pages are a few key details.
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Laptop displaying FDA logo

FDA draft for third-party EUA reviews lacks timeline commitments

Jan. 30, 2024
By Mark McCarty
The U.S. FDA has redrafted an existing guidance for third-party reviews of 510(k) submissions to include submissions under the emergency use authorization (EUA) program, which generally speaking should be good news. The problem with the draft is that these third parties will have to interact frequently and substantively with the FDA in EUA reviews, and the lack of prescribed timelines in the FDA draft suggests that while the use of third parties may help the agency manage any future EUA workloads, the total turnaround time for these applications might not be significantly better than was seen during the COVID-19 pandemic.
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Brain with stroke illustration

UK’s NICE easing into artificial intelligence for stroke

Jan. 26, 2024
By Mark McCarty
To date, developers of digital health technologies have had little luck with coverage and reimbursement, but the picture is slowly improving. The U.K.’s National Institute for Health and Care Excellence (NICE) has endorsed two artificial intelligence (AI) algorithms for diagnosis of stroke, although this is limited to an evidence generation framework that puts the sponsors on the hook for generating the data that will allow unlimited use in the U.K.’s trusts.
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Digital brain and silhouette

FDA’s device center meets MDUFA hiring goals in fiscal 2023

Jan. 25, 2024
By Mark McCarty
The U.S. FDA’s device center has at times struggled to make the volume of hires under the reigning Medical Device User Fee Agreement (MDUFA), but that wasn’t a problem in fiscal year 2023.
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Gavel and scales

Device maker convicted for forgery of FDA documents

Jan. 25, 2024
By Mark McCarty
The U.S. Department of Justice (DOJ) has announced a conviction obtained in federal court of an employee of a medical device manufacturer who was charged with forging documents that purported that his employer had obtained clearance for two medical devices. Peter Stoll III, who was employed by Aesculap Inc., of Center Valley, Pa., will serve 12 months in prison and a year of supervised release in one of the most egregious examples of fraudulent med tech behavior in recent memory.
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U.S. Capitol building

New effort to reform patent eligibility in play in US Senate

Jan. 24, 2024
By Mark McCarty
The ongoing controversy over patent subject matter eligibility gained new momentum via a Jan. 23 U.S. Senate hearing, during which a bipartisan pair of senators once again pushed the argument that current jurisprudence for subject matter eligibility is hampering U.S. life science companies.
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EU flags

European Commission provides another delay in IVDR compliance deadlines

Jan. 24, 2024
By Mark McCarty
The European Commission (EC) has proposed another delay in the compliance deadlines for the In Vitro Diagnostic Regulation (IVDR) that eases the existing timelines by roughly two and a half years. The news was welcomed by Medtech Europe, which nonetheless pressed the EC and others to patch up some of the issues that led to the new extensions in the first place.
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