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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FDA seeks public comment on a new information collection request to support medical device tracking under the Paperwork Reduction Act. The Food and Drug Administration (FDA) has published a notice in the Federal Register announcing a proposed information collection activity related to the...
The FDA seeks input on evidence requirements for RASDs, including AI integration, cybersecurity, and clinical performance, to shape future clearance pathways. The FDA has released draft guidance outlining recommendations for premarket submissions of robotically-assisted surgical devices (RASDs),...
HHS Request for Information explores whether deceased donor islet cells should be regulated as organs under OPTN policy or as cell products, impacting transplant access and regulatory pathways for Type 1 diabetes therapies. The Department of Health and Human Services (HHS) has opened a public...
Aligning regulatory language with updated FD&C and PHS Acts to support alternative testing methodologies and reduce animal testing emphasis. The FDA is proposing to amend its regulations by replacing references to "animal" tests or studies with "nonclinical" tests or studies, and adding...
The meeting will examine pathogen-agnostic sequencing applications in outbreak response and establish a public docket for comment. The Food and Drug Administration (FDA) has announced a public meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee, scheduled to...
FDA issued a discussion paper seeking stakeholder input on regulatory approaches for GenAI-enabled medical devices due to concerns about unique risks like hallucinations and confabulations. The U.S.
FDA requests public comment on proposed information collection requirements for medical device tracking under the Paperwork Reduction Act, with comments due November 10, 2026. The Food and Drug Administration (FDA) has announced a 60-day public comment period on proposed information collection...
FDA proposes a 60-day comment period for a survey of healthcare providers to inform pregnancy exposure registry enrollment and improve maternal health safety data collection. The Food and Drug Administration (FDA) has issued a Federal Register notice announcing a proposed information collection...
A 60-day comment period begins for the FDA's information collection related to HCT/P regulations under the Paperwork Reduction Act. The U.S.
FDA requests public comment on continuing collection of data from medical device manufacturers regarding product removals and corrections to support post-market surveillance and safety monitoring. The Food and Drug Administration (FDA) has announced a 60-day public comment period for a proposed...
This notice allows stakeholders to comment on FDA's plan to collect and manage voluntary reports of regulatory misconduct involving medical devices and radiological health products. The Food and Drug Administration (FDA) has published a notice in the Federal Register announcing a 60-day public...
FDA's forthcoming generative AI device guidance and Epic's user group meeting reveal accelerating healthcare AI adoption with regulatory signposts for developers. The FDA has committed to issuing new guidance for regulating generative AI-powered medical devices, addressing a growing gap in...
FDA promises forthcoming guidance on generative AI medical devices, signaling regulatory clarity for developers of AI-driven healthcare technologies. Rick Abramson, head of digital health policy at the FDA, stated that the agency expects to issue regulatory guidance on policies regarding...
FDA seeks OMB clearance for a proposed information collection related to IND application requirements, with public comment open until September 16, 2026. The Food and Drug Administration (FDA) has announced that a proposed collection of information has been submitted to the Office of Management...
FDA seeks to reclassify diagnostic endoscopic light source systems for bladder cancer detection to Class II with special controls, eliminating premarket approval requirements. The FDA is proposing to reclassify diagnostic endoscopic light source systems (product code OAY) from Class III...
FDA seeks comment on classifying certain accessories as Class I devices, where general controls alone would ensure safety and effectiveness. The Food and Drug Administration (FDA) has published a proposed list of medical device accessories that it believes should be classified as Class I devices...
The change lowers regulatory burden for companion diagnostic ISH tests while maintaining safety and effectiveness through special controls. The FDA has issued a final order reclassifying in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic...
FDA proposes to require formal submission of GRAS notices for substances claimed to be Generally Recognized as Safe, ending the voluntary notification system for food ingredients. The Food and Drug Administration (FDA) is proposing to amend its regulations to require the submission of Generally...
FDA's proposal would reduce regulatory burden for DBT systems by moving them from premarket approval to special controls with 510(k) pathway, while establishing new device classification and safety requirements. The Food and Drug Administration (FDA) is proposing to reclassify digital breast...
HHS, FDA, and ONC officials convene private meetings with industry to accelerate AI use in healthcare settings. Federal health officials from HHS, FDA, and ONC have initiated a series of closed-door meetings with technology companies, researchers, and lobbyists focused on accelerating the...
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 requests 60-day public comment on information collection for its ASCA Program supporting medical device conformity assessment under the Paperwork Reduction Act. The Food and Drug Administration (FDA) has announced a 60-day public comment period for its proposed information collection...
FDA requests public comment on proposed information collection for its Medical Device Voluntary Improvement Program under PRA requirements. The Food and Drug Administration is announcing a 60-day public comment period on a proposed information collection associated with the Medical Device...
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.
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