USA – FDA updates off-the-shelf software guidance to reflect least burdensome approach
The US Food and Drug Administration (FDA) has reissued a final guidance on off-the-shelf (OTS) software used by medical devices, which aims to reduce...
USA – FDA details proposed 510(k) modernization with trio of draft guidances
The US Food and Drug Administration (FDA) has announced new steps it is taking to modernize the 510(k) program, which include updates on its...
International – E-labeling and digital transformation in healthcare
This article examines the regulations for electronic labeling (e-labeling) for prescription drugs and medical devices in Japan, Brazil, Singapore, the EU and US, Canada,...
Europe – Evaluation clinique : retours d’expérience d’un organisme notifié
Avec le Règlement (UE) 2017/745 sur les dispositifs médicaux (RDM), l’évaluation clinique est devenue une étape centrale dans l’évaluation de la conformité des produits,...
UK – Three new UK Approved Bodies to certify medical devices announced by the...
TÜV SÜD, Intertek, and TÜV Rheinland UK join the four current UK Approved Bodies, almost doubling current capacity for the certification of medical devices...
UK – Medical devices: UK approved bodies
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)...
Europe – Team-NB asks for regulatory clarity and for manufacturers to not delay MDR...
Notified bodies (NB) say that while extending the deadline to transition to EU Medical Device Regulation (MDR) has been a positive move, there is...
USA – FDA issues final guidance on obtaining informed consent in drug and device...
The US Food and Drug Administration (FDA) on Tuesday announced it has finalized guidance to help institutional review boards (IRBs), clinical investigators, and sponsors...
UK – NICE recommends AI technologies for radiotherapy treatment planning
The recommendation aims to speed up the time taken to produce outlines of healthy organs, in order to help target cancer cells while avoiding...
UK – Squamous cell carcinoma (SCC) and different types of lymphomas occurring in the...
MHRA is aware of a very small number of cases of squamous cell carcinoma (SCC) and different types of lymphoma, found within the fibrous capsule...
