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.
Every brief below links to its primary source — start with the free feed, or upgrade to Pro for the full analysis.
CISA warns that multiple flaws in dcm4chee-arc-light versions 5.35.1 and earlier enable attackers to delete medical images, leak patient data, and disrupt PACS operations without authentication. The Cybersecurity and Infrastructure Security Agency (CISA) has issued an advisory (ICSMA-26-288-02)...
Sources
Federal officials are working behind the scenes to align state AI testing initiatives with federal oversight as more states launch clinical AI sandboxes. FDA and CMS officials are actively coordinating to avoid a regulatory logjam between federal oversight and state-level AI sandbox programs for...
FDA invites public comment on its proposed information collection for electronic record and signature provisions under 21 CFR Part 11, with implications for compliance and system design. The Food and Drug Administration (FDA) has issued a notice in the Federal Register requesting public comment...
Clarifies regulatory boundaries for digital health apps that interact with prescription drugs, aiming to reduce uncertainty for developers. The FDA has finalized its guidance on prescription drug use-related software (PDURS), defining which digital health applications that interact with...
The AMA calls for FDA to establish a risk-based framework for generative AI oversight to clarify accountability and support responsible innovation in healthcare. The American Medical Association (AMA) is urging the U.S.
FDA official Rick Abramson argues that generative AI-enabled medical devices should be assessed using standards similar to those applied to human clinicians due to their evolving, adaptive behavior. Rick Abramson, director of the FDA’s Digital Health Center of Excellence and a radiologist by...
Standardized FHIR interfaces improve AI device evaluation, monitoring, and real-world evidence generation by ensuring consistent, auditable data inputs from EHRs. SMART Health IT has submitted formal comments to the FDA regarding its discussion paper on generative AI-enabled medical devices,...
FDA's new draft guidance expands pre-market testing requirements for robotic-assisted surgical devices to include cybersecurity, human factors, and operating room integration, with comments due November 24. The FDA has published draft guidance on pre-market testing for robotically-assisted...
FDA's submission of the MedSun information collection for OMB review signals continued focus on post-market surveillance of medical devices through structured adverse event reporting. The Food and Drug Administration has submitted a proposed information collection request to the Office of...
Utah's health AI sandbox may allow testing of AI tools without FDA oversight, creating potential conflicts between state innovation programs and federal medical device regulations. Utah's regulatory sandbox for health AI technologies allows companies to test AI applications without meeting...
FDA signals upcoming AI/ML regulatory framework updates slated for 2027 as healthcare technology adoption accelerates The FDA has outlined its plans for issuing new artificial intelligence and machine learning guidance documents in 2027, according to reporting by STAT+.
FDA seeks public comments on safety and design elements for early-phase ibogaine trials as HHS-funded studies in opioid use disorder and PTSD prepare to launch. The FDA is issuing a Request for Information (RFI) to gather public input on the design and safety considerations for early-phase...
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...
FDA will hold a hybrid public meeting and accept written comments through November 25, 2026, on recommendations to reauthorize the Biosimilar User Fee Act before its current authority expires in September 2027. The Food and Drug Administration (FDA) announced a hybrid public meeting to discuss...
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 is opening a public docket to gather comments on statistical methods for rare disease clinical investigations ahead of a RISE workshop to inform future guidance. The FDA has established a public docket (2026-18805) to collect comments on statistical considerations for the design of rare...
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's determination of the regulatory review period for Andembry enables patent term restoration under the Hatch-Waxman Act, directly impacting commercial exclusivity for this biological product. The Food and Drug Administration (FDA) has determined the regulatory review period for Andembry, a...
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...
Fully-sourced weekly briefs, tracked from proposal to final.
Create free account