USA – FDA aims to clarify device malfunction summary reporting requirements
In a new draft guidance issued on Thursday, the US Food and Drug Administration (FDA) aims to clarify how manufacturers can voluntarily submit malfunction...
USA – FDA draft guidance covers low-level light therapy devices
The US Food and Drug Administration (FDA) has published a draft guidance for low-level light therapy (LLLT) devices, or photobiomodulation (PBM) devices, which are...
France – Consultation publique sur le guide d’aide au choix des dispositifs médicaux numériques...
De très nombreuses solutions numériques sont aujourd’hui utilisées dans le cadre de soins courants. Pourtant, leur utilité ou leur pertinence par rapport à l’arsenal...
USA – Diversity plan draft guidance on track before year end, FDA official says
The US Food and Drug Administration (FDA) is on track to publish a draft guidance on diversity plans before year’s end, which will take...
USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms
The US Food and Drug Administration (FDA) has released a finalized list of alternatives and streamlined mechanisms for current good manufacturing practice (CGMP) of...
USA – FDA finalizes guidances on device post-approval studies, postmarket surveillance
The US Food and Drug Administration (FDA) on 7 October released two final guidances to assist manufacturers of moderate- to high-risk medical devices to...
Europe – Nanoparticle-based drug delivery systems
EVO-NANO aims to create an integrated cross-disciplinary platform for the artificial evolution and assessment of nanoparticle-based drug delivery systems. Nanoparticles (NP) are increasingly being...
USA – New US FDA Guidance on Human Factors Engineering for Medical Devices
The US Food and Drug Administration has issued a new draft human factors engineering (HFE) guidance this week titled: Content of Human Factors Information in...
Europe – Update – MDCG 2020-16 Rev.2 – Guidance on Classification Rules for in...
This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic...
Europe – Amendement des normes IEC 60601 : les impacts sur l’évaluation des DM
Publiée pour la première fois en 1977, la norme IEC 60601-1 décrit les exigences générales de sécurité et de performances applicables aux dispositifs électro-médicaux....
