FDA
FDA classifies external congestion stimulator into class II
FDA issued a final rule classifying the external mechanical stimulator for congestion relief into class II with special controls intended to provide reasonable assurance of safety and effectiveness.
Read the official sourceMHRA
MHRA addresses medical device clinical investigation notifications
MHRA published guidance on notifying the agency of an intention to conduct a clinical investigation for medical devices.
Read the official sourceMHRA
MHRA updates GCP inspection information
MHRA published guidance covering good clinical practice inspections for clinical trials of medicines.
Read the official sourceMHRA
MHRA outlines steps for bringing medical device software to market
The guidance provides an overview of key regulatory steps and considerations for bringing software as a medical device to market in Great Britain and Northern Ireland.
Read the official sourceMHRA
MHRA issues interim givinostat risk mitigation advice
Following international reports of deaths in patients with Duchenne muscular dystrophy taking givinostat, MHRA reviewed the cases and associated evidence and proposed product information updates.
Read the official sourceMHRA
MHRA publishes directory of implemented ICH guidelines
MHRA published a directory of current ICH guidelines implemented by the agency.
Read the official sourceWhy this matters
Regulatory teams have several operational references to review across device classification, investigation notifications, inspection readiness and software market access. The givinostat communication also warrants attention to MHRA’s interim advice and proposed product information changes, while the ICH directory provides a practical reference for guidelines implemented by the agency.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.