USA – This Week at FDA: User fee update, Califf nomination…

Welcome to another edition of This Week at FDA! There were some major developments this week with potential ramifications for FDA in the coming...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – New Notified Body designated to IVD Directive in Europe

An interesting fact was overlooked in the headlines last year: Since November 5, 2021 a new Notified Body has been designated for the In-Vitro...

USA – US FDA lays out post-COVID EUA transition plans for medical devices

The US Food and Drug Administration has published transition plans for medical devices currently marketed under Emergency Use Authorizations (EUAs) during the COVID-19 public...

International – Le CES et la Banque mondiale mettent la santé des femmes à...

LAS VEGAS (TICpharma) - Le Consumer Electronics Show (CES), qui s'est tenu à Las Vegas du 4 au 7 janvier, et la Banque mondiale...

USA – Draft Guidance : Transition Plan for Medical Devices Issued Emergency Use Authorizations...

FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19)...
With 6 months until new EU medical device rules, what's the state of play?

Europe – IVDR: European Commission publishes second batch of harmonized standards

On Thursday, the European Commission officially recognized five additional harmonized standards for in vitro diagnostics in order to satisfy conformity requirements under the In Vitro Diagnostic Medical Devices...

USA – FDA seeks comment on device shortage reporting guidance

The US Food and Drug Administration (FDA) on Monday released draft guidance on the new notification requirements for reporting medical device discontinuances and manufacturing...
Contact Lenses: CDRH Drafts Guidance on Performance Criteria to Support 510(k)s

USA – FDA issues draft guidance on assessing physiologic closed-loop control devices

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) in late December issued a draft guidance on developing medical devices with...

Europe – European Commission publishes second batch of harmonized standards under MDR

The European Commission on Tuesday officially recognized nine harmonized standards for medical devices that device makers can reference in order to satisfy conformity requirements...

Europe – Euro Roundup: MHRA shares guidance on coordinated assessment pathway for device trials

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the coordinated assessment pathway it is piloting to streamline the review...

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