UK – Regulation of devices in Northern Ireland
The Medicines and Healthcare products Regulatory Agency (MHRA) is the Competent Authority for medical devices and in vitro diagnostic (IVD) devices in Northern Ireland.
This...
USA – FDA device center guidance priority lists targets COVID, digital health
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has published its FY2023 guidance priority lists. Much of the...
USA – Legacy devices report highlights need for data to support future policies
More data is needed to understand the risks legacy connected medical devices pose to the healthcare system, particularly in their vulnerability to cyberattack. That...
USA – FDA proposes framework for human factors information in device submissions
The US Food and Drug Administration (FDA) last week issued draft guidance outlining a risk-based framework about what human factors information should be included...
USA – MedCon: Consider the device risk management file a ‘living document’
Device manufacturers need to keep their risk documentation up to date throughout the total product life cycle by monitoring production and post-production information, according...
USA – Experts call for data transparency with recalled medical devices
Over the last few years, some patients have been receiving implantable cardioverter-defibrillators (ICDs) that are subject to Class I recalls. These devices have continued...
USA – FDA unveils FY 2025 user fee rates
The US Food and Drug Administration (FDA) has published its user fee rates for fiscal year 2025 across its prescription drug, generic drug, biosimilar,...
USA – FDA finalizes COVID-era guidance on container closure changes
The US Food and Drug Administration (FDA) has finalized a guidance to assist sponsors in reporting common changes made to glass vials and stoppers,...
USA – FDA revamps device software premarket submissions guidance
The US Food and Drug Administration (FDA) this week finalized guidance on the content of premarket submission for software functions in medical devices. The...
USA – FDA guidances keep coming, new device harmonization plan, and more
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical...
