FDA
FDA classifies an OTC infant monitoring device
FDA classified infant pulse rate and oxygen saturation monitors for over the counter use into Class II, subject to special controls identified in the order.
Read the official sourceFDA
Hematopoietic cell enrichment kits enter Class II
FDA classified hematopoietic cell enrichment kits into Class II and identified special controls for the device type.
Read the official sourceFDA
FDA establishes Class II pathway for a home collection STI test system
FDA classified systems that detect nucleic acid from nonviral microorganisms causing sexually transmitted infections using home collected specimens into Class II, with special controls.
Read the official sourceFDA
LASIX oral solution remains eligible as an ANDA reference product
FDA determined that LASIX oral solution, 10 mg/mL, was not withdrawn for safety or effectiveness reasons. FDA may continue approving qualifying ANDAs that reference it.
Read the official sourceEMA
EMA opens consultation on nasal product equivalence
EMA published a draft guideline on requirements for demonstrating therapeutic equivalence for nasal products, with consultation open.
Read the official sourceMHRA
MHRA consolidates real world evidence resources
MHRA published supporting guidance, publications and resources on using real world data and real world evidence in regulatory decision making for medicines and medical devices.
Read the official sourceWhy this matters
The FDA orders define special control pathways for three distinct device types, while the LASIX determination preserves a route for qualifying generic applications. In Europe, the EMA consultation gives stakeholders an opportunity to examine proposed evidence expectations for nasal products, and MHRA's resource collection provides a central reference for real world evidence work.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.