Gulfstream Daily Brief

Regulatory intelligence and policy · Issue 012

FDA finalizes device exemption decision, blood systems guidance, while EMA and MHRA update key resources

Today’s updates cover FDA decisions for radiology software and blood component systems, an EMA ICH cardiac safety resource, and MHRA guidance for medicines and device safety.

By Scott Morvay, Founder September 17, 2026 Official sources linked

FDA

FDA publishes final order on radiology software exemption petition

FDA published its final determination on a requested partial exemption from premarket notification requirements for specified radiology computer aided detection, diagnosis, triage, and notification devices. FDA denied the petition on April 1, 2026.

Read the official source

FDA

FDA finalizes guidance for blood systems using the buffy coat method

The final guidance provides recommendations for developing blood collection, processing, and storage systems used to manufacture blood components through the buffy coat method, including related FDA submissions.

Read the official source

EMA

EMA publishes Step 5 ICH E14/S7B questions and answers

EMA published the Step 5 questions and answers for ICH E14/S7B on clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential.

Read the official source

MHRA

MHRA updates guidance on marketing authorisation variations

MHRA published guidance covering applications for type IA and IB minor variations, type II major variations, and extensions.

Read the official source

MHRA

MHRA publishes national assessment procedure guidance

The guidance explains the MHRA national assessment procedure for medicines marketing authorisation applications.

Read the official source

MHRA

MHRA issues patient hoist and sling safety alert

The national alert addresses deaths and serious harm from falls during transfers and repositioning. MHRA reports an average of two deaths per year since 2015.

Read the official source

Why this matters

Regulatory teams have new final FDA positions to incorporate into device and blood system submission planning, alongside an EMA ICH cardiac safety reference and updated MHRA pathways for medicines applications and variations. The MHRA safety alert also reinforces the role of surveillance evidence in practical device risk controls.

Scott Morvay

Founder, Gulfstream Intelligence

This brief provides general regulatory news and educational information. It is not legal or regulatory advice.