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This proposed session focuses on practical lessons learned from FDA interactions involving software, algorithms, AI/ML, and cybersecurity in safety-critical medical devices. The webinar is targeted toward regulatory, quality, digital health, legal, and executive stakeholders involved in medical device development and commercialization. Topics include common FDA deficiencies across 510(k), De Novo, and PMA submissions; regulatory expectations for AI/ML and PCCP frameworks; software documentation and human factors issues; and cybersecurity expectations such as SBOMs, threat modeling, and postmarket management. The session emphasizes integrating regulatory strategy early in development to reduce delays and review cycles. The featured speaker, Richard Jackson, brings over 25 years of experience in safety-critical systems, AI, software validation, and FDA submissions for Class II and III medical devices.

Join RAPS Boston for an in-depth session unpacking the real world regulatory playbook for AI-enabled wearable devices, from first submission to post-market evolution. Learn from industry leaders Robert Michalik and Tahir Rizvi as they reveal how AI fits within design controls, accelerates development, and reshapes clinical strategy. Gain actionable insights on PCCPs, FDA engagement, and risk mitigation to streamline 510(k) clearance. Leave with a stronger understanding of the AI regulatory landscape and practical insights to support informed decision-making.

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

Most manufacturers of medical devices with artificial intelligence (AI) features are not using predetermined change control plans (PCCPs) to manage changes throughout the device's lifecycle, representing a "missed opportunity" to improve device performance, according to a recent research letter published in JAMA Health Forum.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

LISBON – Regulators and industry representatives highlighted the importance of simplifying regulations to promote innovation at the RAPS Euro Convergence 2026 conference closing plenary; however, they cautioned that oversimplification could backfire and lead to more regulation down the road.

LISBON – A panel of experts representing regulators, industry, and notified bodies gave their opinions on the proposed revision of the EU Medical Device Regulation (MDR) at the RAPS Euro Convergence 2026 conference on Wednesday.

A bimonthly, peer-reviewed publication providing in-depth, evidence-based content, exclusive to RAPS members.

The top lawmaker on the Senate Health, Education, Labor, and Pensions (HELP) Committee published a report this week on reforming the US Food and Drug Administration (FDA). The report argues the changes would cut red tape, make the US more attractive to clinical research, and accelerate the approval of medical products.

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.