The US FDA has issued a draft guidance document providing recommendations on how device firms can collect patient preference data to share with the agency as it reviews applications. The current draft supersedes final guidance the agency published in 2016.
New draft guidance from the US Food and Drug Administration urges medical device firms to incorporate patient preference information (PPI) in the development and evaluation of their products.
The draft document, “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle,” supersedes final guidance the FDA...
The NHS England 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.
In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.
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.
