USA – FDA weight-loss device guidances address clinical and non-clinical studies
A decade in the making, the US Food and Drug Administration (FDA) has published two complementary draft guidances for sponsors developing weight-loss devices. The...
Europe – Medical device competent authority statement on the status of the EU regulatory...
National Competent Authorities have endorsed a consensus statement and shared it with the European Commission on the status of the EU regulatory framework for...
USA – FDA’s final breakthrough devices guidance now includes technologies that address health disparities
Final guidance on the US Food and Drug Administration breakthrough device program includes new language noting that the program now can be used to...
International – 1SO 10933-1:2018 will be replaced by ISO/DIS 10993-1
Biological evaluation of medical devices
Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
This document specifies:
—...
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USA – FDA draft guidance allows AI/ML devices to evolve without requiring new submissions
The US Food and Drug Administration (FDA) published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) products can submit...
USA – FDA recognizes three new international medical device software security standards
The US Food and Drug Administration (FDA) has recognized three new standards related to software security on medical devices. The standards address taking a...
Switzerland – Des paralytiques retrouvent l’usage de leurs mains grâce à un dispositif de...
A l’aide d’un dispositif de stimulation non invasive de la moelle épinière, des personnes paralysées ont retrouvé l’usage de leurs mains.
L’ARCex est un petit stimulateur...
USA – FDA recognizes new medical device sterilization standards
Amid a regulatory effort by the US Environmental Protection Agency (EPA) to limit the use of ethylene oxide (EtO), the Food and Drug Administration...
UK – MHRA e-cigarette and vape products regulator profile
The information below contains the contact details and responsibilities of each of the regulatory bodies involved in the regulation of e-cigarette and vape products...
