Track FDA guidance on digital health, Software as a Medical Device and AI/ML-enabled devices — concise, fully-sourced, and tracked as drafts move to final.
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Global regulators converge on protecting data confidentiality, integrity, and availability for AI-enabled medical devices but apply distinct regulatory architectures, with FDA integrating cybersecurity into quality systems and design controls. The United States FDA, European Union Medical Device...
FDA sets fee schedule for medical device submissions, establishment registrations, and periodic reports under MDUFA V for fiscal year 2027. The Food and Drug Administration has published the medical device user fee rates for fiscal year 2027, covering the period October 1, 2026 through September...
FDA seeks public comment on its infant formula information collection, including electronic Form FDA 3978, labeling, and recordkeeping requirements under the Paperwork Reduction Act. The Food and Drug Administration (FDA) has issued a Federal Register notice announcing a 60-day public comment...
HHS requests stakeholder feedback on training and care delivery models for potential FDA-approved psychedelic drugs in ambulatory settings to support safe administration. On April 18, 2026, President Trump issued Executive Order 14401, "Accelerating Medical Treatments for Serious Mental Illness,"...
FDA proposes to allow distributed manufacturers to register as a single establishment and align foreign establishment requirements with the PREVENT Pandemics Act. The FDA issued a proposed rule to amend drug establishment registration and drug listing requirements for two specific scenarios:...
After receiving more than 7,000 comments on its December 2025 AI Request for Information, HHS is translating public feedback into concrete governance, implementation, and regulatory actions across its agencies. HHS convened a webinar in late June 2026 to share early findings from its December...
The FDA proposes to require foreign tobacco product establishment owners and operators to register and list their products, closing current gaps in Agency oversight. The FDA is proposing regulations to establish the format, content, and procedures for tobacco product establishment registration...
A high-severity server-side request forgery vulnerability in the widely deployed OHIF open-source DICOM viewer can expose authenticated clinicians' OIDC Bearer tokens to attackers — patch to v3.12.2 immediately. CISA issued ICS Medical Advisory ICSMA-26-176-02 on June 25, 2026, disclosing...
A new analysis in npj Digital Medicine traces the growth and evolving patterns of FDA clearances and approvals for digital medical devices over 20 years, offering a data-driven baseline for the field. A peer-reviewed study published in npj Digital Medicine on June 17, 2026 examines two decades of...
The FDA's new framework explicitly acknowledges that AI software changes over time, shifting regulatory emphasis toward ongoing risk controls, transparency, and accountability rather than one-time pre-market review. The Food and Drug Administration has released draft guidance specifically...
A peer-reviewed framework in npj Digital Medicine argues that knowing when to withhold an answer may be as critical as accuracy for safe clinical deployment of large language models. A review article by Michael A.
Fully-sourced weekly briefs, tracked from proposal to final.
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