USA – FDA revises magnetic resonance guidance to reflect updated international standard
The US Food and Drug Administration (FDA) has revised its position on magnetic resonance (MR) with updates to a pair of final guidance documents.
One...
Brazil – Brazil’s ANVISA repeals medical device regulations related to the coronavirus pandemic
Brazilian medical device market regulator ANVISA announced the repeal of several regulations and requirements related to the COVID-19 pandemic which have been deemed no...
USA – FDA official says pandemic reauthorization bill could drive VALID across finish line
A top US Food and Drug Administration (FDA) official said that a pandemic funding reauthorization bill could act as a vehicle for in vitro...
USA – Legal expert: FDA’s CDS software guidance is a ‘disaster’ for industry
The US Food and Drug Administration’s (FDA) final guidance on clinical decision support (CDS) software goes against the statutory language laid out in the 21st Century...
USA – Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
The Food and Drug Administration (FDA or Agency) is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related...
USA – Medical Device Development Tools (MDDT)
The FDA is announcing the qualification of a new tool through the Medical Device Development Tools (MDDT) program, marking the first-ever qualified database under...
USA – FDA panel’s green light on glaucoma wearable device offers hope in sight
On 21 March, an advisory panel to the U.S. Food and Drug Administration gave its unanimous blessing to a piece of wearable technology that...
USA – Medtech groups warn EPA of ‘devastating’ impact of proposed EtO rules
Two proposed regulations to limit the use of ethylene oxide (EtO) and the facilities that use the sterilizing agent could have a “devastating” impact...
USA – Use of International Standard ISO 10993-1, « Biological evaluation of medical devices –...
FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications...
USA – FDA Proposes New Ban of Electrical Stimulation Devices for Self-Injurious or Aggressive...
Today, the U.S. Food and Drug Administration (FDA) is proposing a ban of electrical stimulation devices (ESDs) intended to reduce or stop self-injurious or...
