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The International Medical Device Regulators Forum (IMDRF) has finalized a technical document outlining how regulatory agencies may adopt predetermined change control plans (PCCP). The document lists principles for regulators to consider when developing their own PCCP regulations, as well as key elements to include in manufacturers' PCCPs.

Two recent papers published in JAMA have highlighted the potential need for additional regulatory scrutiny for low-risk digital health technologies used by consumers.

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, the acting FDA commissioner wrote an op-ed promoting the agency’s efforts to incentivize domestic drug manufacturing, FDA announced new grants for using digital health technologies (DHT) for drug development, and it approved an over-the-counter combination of two popular pain drugs.

Industry and academic stakeholders have asked the US Food and Drug Administration (FDA) to clarify its objectives and plans for a proposed pilot program to evaluate how artificial intelligence (AI) technologies can help improve early-phase clinical trials. They also said the agency should develop a governance structure with specific metrics and goals and consider aligning its thinking with other regulators.

Researchers from the European Medicines Agency (EMA) have published a paper on regulatory research priorities for AI across the medicine lifecycle.

Industry groups have asked the US Food and Drug Administration (FDA) to provide more clarity about its regulatory approach to digital health technologies (DHTs), as well as for greater flexibility in their use in clinical trials.

COLUMBUS, OH – The difference between an anomaly and a defect in product software can be confusing, but it is important to identify which is which to properly handle problems that crop up in product software, two panelists recently told attendees, at the 2026 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.

The healthcare product landscape in Europe is undergoing significant transformation—from multiple legislative overhauls to the rapid adoption of artificial intelligence (AI) and other boundary-pushing technologies. For regulatory professionals attending RAPS Euro Convergence 2026 in Lisbon, the meeting is an opportunity to lean into community to stay on top of the myriad changes coming their way.

COLUMBUS, OH – The US Food and Drug Administration’s (FDA) top medical device official touted her center’s recent accomplishments and provided an update on several ongoing initiatives at the 2026 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.

The International Medical Device Regulators Forum (IMDRF) has released a draft technical document to create a harmonized set of best practices in mitigating risks associated with the use of artificial intelligence (AI)-enabled medical devices throughout their product life cycle.