BioWorld - Tuesday, May 6, 2025

Articles by Mark McCarty

US FDA’s tweak to COVID remote monitoring guidance a nod to health equity

Oct. 24, 2023
By Mark McCarty
The U.S. FDA recently released a guidance for non-invasive remote monitoring devices, which were granted tremendous leniency during the COVID-19 pandemic as a means of reducing the demands on hospitals and doctor’s offices. That policy has been extended for the non-COVID era as part of the agency’s strategic plan to improve health equity by ensuring that access to digital health technologies is enjoyed by diverse American populations in a variety of health care access-challenged geographical areas.
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2023 Med Tech Conference

FDA’s Shuren says agency decidedly moving away from up-or-down vote at advisory hearings

Oct. 12, 2023
By Mark McCarty

The FDA town hall on the final day of the 2023 edition of the Med Tech Conference included the usual patter about the achievements at the agency’s Center for Devices and Radiological Health (CDRH), but a few useful nuggets of information nonetheless slipped through in this year’s session. CDRH director Jeff Shuren acknowledged that the agency is steering device advisory committee hearings away from votes on whether to approve a product, an approach he said is under consideration at the agency’s other product centers as well.


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2023 Med Tech Conference

EU’s notified body dilemma easing, but competent authorities continue to muddle the picture

Oct. 11, 2023
By Mark McCarty
Concerns over the EU’s agonizingly clunky roll-out of the Medical Device Regulation (MDR) has largely focused on the capacity of notified bodies to manage the task of recertifying CE marks for legacy devices, but a new problem has emerged that promises to add yet more drag to the process. Amie Smirthwaite, senior vice president for innovation at RQM+, said EU member states’ competent authorities seem bent on pressing notified bodies (NBs) to treat guidance by the Medical Device Coordination Group (MDCG) as regulation, with the net result that “you almost need guidance for the guidance” in order to successfully navigate the EU market.
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U.S. FDA headquarters

Abiomed stung by FDA’s final guidance for clinical decision support in warning letter

Oct. 11, 2023
By Mark McCarty
The U.S. FDA’s final guidance for clinical decision support (CDS) systems may be the subject of two citizen’s petitions requesting the agency scrap the guidance and start over, but that doesn’t mean the agency is not enforcing the terms of the guidance. Danvers, Mass.-based Abiomed Inc., took in a Sept. 19 warning letter stating that the company’s Impella Connect system qualifies as a CDS product because it provides “patient-specific medical information to detect a life-threatening condition,” an interpretation that is sure to intensify the larger debate about whether the CDS final guidance is an extra-statutory exercise in regulatory engineering.
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Laptop displaying FDA logo
2023 Med Tech Conference

PCCP concept at risk of being subsumed in debate over artificial intelligence

Oct. 10, 2023
By Mark McCarty
The U.S. FDA’s draft guidance for predetermined change control plans (PCCPs) is one of the more innovative regulatory proposals in recent memory, although the FDA is not statutorily required to limit this policy to artificial intelligence (AI) and machine learning (ML) products. Nonetheless, the PCCP concept is starting to show signs of being consumed by the debate over AI and ML medical software, so much so that industry may be losing sight of the opportunities the PCCP concept offers in other types of medical technologies.
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2023 Med Tech Conference

Advamed’s Whitaker more bullish on VALID Act in light of FDA draft rule for LDTs

Oct. 10, 2023
By Mark McCarty

The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) was a long time in coming, much longer than any legislative proposals to overhaul the agency’s regulatory mechanisms for these tests. Nonetheless, Scott Whitaker, president and CEO of the Advanced Medical Technology Association (Advamed), believes that the FDA draft rule is likely to prompt Congress to pass the Verifying Accurate, Leading-edge IVCT development (VALID) Act, a development that would truncate an FDA final rule that would almost certainly face litigation.


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2023 Med Tech Conference

Congress seen as having leeway to bring LDT user fees on board midstream in MDUFA VI

Oct. 9, 2023
By Mark McCarty

The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) carries an exceptionally ambitious timeline of completion and enactment by the time the next user fee agreement kicks in, and some see big problems with the timeline laid out by the agency. However, the FDA’s Elizabeth Hillebrenner said that Congress can tweak user fee legislation such that a specific set of user fee sources kicks in off schedule, thus giving the agency a little more leeway in completing any activity related to the proposed rule.


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US FDA’s updated guidance for susceptibility tests incorporates change control plans

Oct. 6, 2023
By Mark McCarty
The FDA’s draft guidance for predetermined change control plans (PCCPs) is just that, a draft guidance, but that has not stopped the agency from incorporating the underlying concepts into existing guidances. An example of this is the September 2023 guidance for antimicrobial susceptibility test (AST) system for breakpoints in device labeling, a document that represents a jarring update to the legacy version published in 2009.


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