Two newly finalized guidance documents from US FDA help broaden the scope of acceptable manufacturer communications. One addresses communications with payers, while the other discusses communications that are consistent with approved labeling.
A recent move by US FDA clarifies protections for manufacturers that might want to discuss a device treatment regimen with an insurance company, or share suggestions about device usage that aren’t included in the labeling with physicians.
The agency announced June 12 that it finalized two question-and-answer format guidance documents related to manufacturer communications. The first addresses...
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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.
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.
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.
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.
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.
There is still no clarity on how life sciences will be treated in the final agreement.
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.
