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FDA, Industry Still Grappling With 'Consistent-With-Labeling' Guidance

 
• By Elizabeth Orr

In June, US FDA gave manufacturers permission to discuss their devices in ways that strayed outside the official labeling language as long as they met certain standards. FDAers and lawyers discussed the practical implications of that rule at a recent conference in Washington DC.

Printing at high speed on offset machine. Label, Rolled Up, Printing Out, Group of Objects, Merchandise

A guidance document finalized in June gave manufacturers more freedom to discuss devices in ways not specifically included in the labeling, but US FDA and industry are still feeling out the limits of the protection.

That was the message from two sessions at the Food & Drug Law Institute’s Advertising and Promotions Conference held this...

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More from Regulation

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 
• By Natasha Barrow

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 
• By Amanda Maxwell

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

HHS Suggests Drastic Reductions To Skin Substitute Payments

 
• By Elizabeth Orr

The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.

International Reliance Gets UK MHRA OK In Drive For Agile Pre-Market Regulation – CE Marking Next

 
• By Ashley Yeo

The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.

More from Policy & Regulation

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 
• By Natasha Barrow

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

EU/US Trade Deal Raises Questions For Medtech

 
• By Amanda Maxwell

There is still no clarity on how life sciences will be treated in the final agreement.

NICE To Consult On UK Late-Stage Healthtech Assessments

 
• By Ashley Yeo

NICE’s three-pronged lifecycle approach to healthtech evaluations includes late-stage assessments (LSA), which will be the focus of a short consultation in August.