FDA
FDA opens docket on ibogaine clinical trial design
FDA is seeking comments, data, and information on dose selection, escalation, care settings, safety monitoring, eligibility, stopping rules, and oversight for early phase ibogaine trials. The input may inform FDA review of related INDs.
Read the official sourceFDA
Certain clinical toxicology tests gain 510(k) exemption
FDA has exempted certain class II clinical toxicology test systems from premarket notification requirements, subject to limitations. The exemption is immediately effective.
Read the official sourceFDA
Hereditary cancer sequencing tests classified as class II
FDA classified high throughput DNA sequencing test systems for hereditary cancer predisposition assessment as class II devices with special controls.
Read the official sourceFDA
Hyperoxia monitoring devices placed in class II
FDA classified hyperoxia monitoring devices used alongside pulse oximetry as class II devices with special controls.
Read the official sourceMHRA
UK government responds to healthcare AI recommendations
The government published its response explaining how it intends to take forward recommendations from the independent National Commission on the regulation of AI in healthcare.
Read the official sourceMHRA
AI Airlock Phase 3 applications open
Applications are now open for Phase 3 of the UK regulatory sandbox for AI enabled medical devices.
Read the official sourceWhy this matters
FDA’s ibogaine docket gives stakeholders an opportunity to inform how specific trial safeguards may be considered in IND review. Its device orders establish clearer pathways for several technologies, while the UK updates show healthcare AI policy moving from recommendations toward implementation and regulatory testing.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.