FDA
FDA classifies AI cervical cytology imaging systems
FDA classified digital cervical cytology slide imaging systems with artificial intelligence algorithms as Class II devices subject to special controls.
Read the official sourceFDA
FDA classifies mild cognitive impairment prognostic software
FDA classified prognostic assessment software for mild cognitive impairment as Class II with special controls.
Read the official sourceFDA
FDA classifies wearable orthopedic vibration devices
FDA classified wearable vibration devices for orthopedic use as Class II devices subject to special controls.
Read the official sourceMHRA
MHRA explains use of non-OECD MAD data
New guidance addresses non-clinical data generated outside the OECD Mutual Acceptance of Data framework when supporting UK Clinical Trial Authorisation applications.
Read the official sourceMHRA
MHRA and NICE seek digital mental health feedback
The agencies opened a survey seeking feedback on resources developed through the Wellcome Digital Mental Health Technologies programme.
Read the official sourceMHRA
MHRA and NICE outline real-world evidence dialogue
A joint scientific dialogue is intended to support regulatory and health technology assessment decisions across the product lifecycle.
Read the official sourceEMA
EMA posts Respreeza safety communication
The communication addresses the risk of missed doses and potential infection due to compromised vial integrity.
Read the official sourceWhy this matters
The FDA rules establish codified Class II pathways and special controls for three distinct technologies. In the UK, MHRA is clarifying how certain non-clinical evidence may support trial applications while working with NICE on digital health and real-world evidence. The EMA communication also requires attention to a specific product safety issue.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.