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Generative artificial intelligence (AI) tools in clinical practice should have an oversight framework that resembles how human clinicians are trained and certified, with continuous learning, regular assessments, and supervised practice, experts argued in a recent Viewpoint article published in JAMA Health Forum.

The US Food and Drug Administration (FDA) has reissued a final guidance on quality system management considerations for medical device cybersecurity following the agency's transition from the Quality System Regulation (QSR) to the Quality System Management Regulation (QMSR).

BRUSSELS – The European Commission's proposed revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) include specific changes to the regulation of medical device software, including medical device artificial intelligence (AI), in Europe. According to experts who spoke at the 2026 DIA-RAPS Combination Products in the EU conference, the proposed changes would clarify how the products are classified and could delay the implementation of the EU Artificial Intelligence (AI) Act.

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have issued a joint list of guiding principles of good artificial intelligence (AI) practices when using the technology to develop drugs. Key considerations of the principles include taking a risk-based total product lifecycle approach and adhering to updated AI standards.

In a move meant to bolster the adoption of artificial intelligence (AI)-enabled digital health products, the US Food and Drug Administration (FDA) on Tuesday updated two guidances to ease its oversight of general wellness devices and clinical decision support (CDS) software.

Industry groups and companies in the medical device sector are urging the US Food and Drug Administration (FDA) to utilize its existing quality management systems (QMS) requirements to oversee the performance of artificial intelligence (AI)-assisted medical devices. They recommend against creating a new oversight framework for this purpose.

PROVIDENCE, RI – A US Food and Drug Administration (FDA) official said that predetermined change control plans (PCCPs), while not required, can reduce the need to submit supplemental applications for medical devices and device-led combination products that incorporate artificial intelligence (AI).

Representatives from the American Psychological Association and American Psychiatric Association offered the US Food and Drug Administration (FDA) a set of recommendations for how to think about regulating generative artificial intelligence (AI)-enabled digital mental health medical devices in two presentations at the agency's Digital Health Advisory Committee (DHAC) meeting last week.

ROTTERDAM, NETHERLANDS – A panel of experts raised concerns about the recently enacted EU Artificial Intelligence (AI) Act, which they said poses a significant burden on new medtech products and could keep some developers from entering the EU market.

During the second meeting of the US Food and Drug Administration's (FDA) Digital Health Advisory Committee (DHAC), members of the panel seemed shocked and, at times, lost for words when grappling with the agency's discussion questions surrounding the potential regulation of generative artificial intelligence (AI)-enabled digital mental health medical.

ROTTERDAM, NETHERLANDS – As medtech companies look to incorporate artificial intelligence (AI) into their products, Fernanda Ferraroli Paro, a regulatory compliance specialist at Compliance & Risk, said that EU law expects them to be more proactive and adopt a lifecycle management approach to their products.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week, FDA's drug center is left without a leader after its director resigned over the weekend, the agency added six new drugs to its Commissioner's National Priority Voucher (CNPV) pilot, and the agency issued warning letters to a slew of online companies for illegally marketing unapproved botulinum toxin products online.

ROTTERDAM, NETHERLANDS — Artificial intelligence (AI) tools can be useful when conducting clinical evaluations during the medical device development process, but they have significant limitations that manufacturers should be aware of, according to experts who spoke at the RAPS European Lifecycle Management conference last week.

ROTTERDAM, NETHERLANDS — In addition to meeting the requirements of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), Erik Vollebregt, a partner at Axon Lawyers, said that manufacturers must also consider the recently enacted EU Artificial Intelligence (AI) Act as part of their overall strategy. While there are some uncertainties about conforming to the new law, he said stakeholders need to address it as a part of the overall regulatory strategy.

ROTTERDAM, NETHERLANDS — A panel of experts at RAPS' European Digital Technology and Software Conference on Thursday urged regulatory professionals to embrace artificial intelligence (AI). They said the technology is already here, and while there are initial shortcomings, regulatory professionals can help adopt the technology for their organizations in a safe and responsible manner.