Gulfstream Daily Brief

Regulatory intelligence and policy · Issue 043

FDA updates drug delivery guidance and device classifications, MHRA expands Casgevy authorization

FDA published revised draft guidance for drug delivery devices and finalized four class II device classifications. In the UK, MHRA extended Casgevy’s authorization and announced a Class 2 medicines recall.

By Scott Morvay, Founder October 30, 2026 Official sources linked

FDA

FDA revises draft guidance on drug delivery performance

The revised draft replaces the 2024 draft and recommends how to develop and organize performance information for devices and combination products that deliver drugs or biological products.

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FDA

FDA classifies an over-the-counter sleep apnea risk assessment device

FDA classified the device type as class II with special controls that will become part of the codified classification language.

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FDA

FDA classifies spinal imaging systems for neuraxial procedures

FDA classified the device type as class II with special controls.

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FDA

FDA classifies software aided skin cancer diagnostic devices

FDA classified physician used adjunctive diagnostic software for suspicious skin lesions as class II with special controls.

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FDA

FDA classifies radiology software for fibrotic lung disease referrals

FDA classified the software as class II with special controls.

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FDA

FDA further delays an estrogen-androgen drug efficacy resolution

FDA extended the effective date of its May 2026 notice from November 4, 2026, to May 4, 2027, to consider issues raised by interested parties.

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MHRA

MHRA extends Casgevy authorization to children aged five and older

The UK authorization now covers children aged five and older with severe sickle cell disease and transfusion dependent β-thalassemia.

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MHRA

MHRA announces Class 2 recall for one lercanidipine batch

Accord-UK is recalling one batch of Lercanidipine Hydrochloride 10mg Tablets following a packaging mix-up involving the incorrect strength.

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Why this matters

The revised FDA draft sets out expectations for presenting drug delivery performance data, while the new class II orders establish special controls for several device types. The UK actions span authorization and postmarket quality oversight, giving regulatory teams several distinct developments to track.

Scott Morvay

Founder, Gulfstream Intelligence

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