USA – FDA posts final guidance on device-specific performance criteria

FDA has released three device-specific guidance documents detailing performance criteria in support of its Safety and Performance Based Pathway. The texts cover magnetic resonance (MR) receive-only...
Le TROD de l'angine à streptocoque bientôt réalisé en pharmacie sans prescription médicale

USA – HFE for over-the-counter medical devices and combination products: Nice to have or...

If you work for one of the many companies developing an over-the-counter (OTC) medical device or combination product, you might be wondering: Do I...
Un hôpital chinois implante des vertèbres thoraciques imprimées 3D

China – Un hôpital chinois implante des vertèbres thoraciques imprimées 3D

Des médecins chinois ont réalisé avec succès une opération chirurgicale à Beijing en remplaçant trois vertèbres thoraciques érodées par une tumeur par des implants...

Europe – EU expands use of BioMerieux COVID-19 test

BioMérieux (OTC:BMXXY) announces the expansion of its ARGENE range for the detection of SARS-CoV-2. As a complement to nasopharyngeal swab specimens, the singleplex SARS-CoV-2 R-GENE real-time PCR test...

USA – FDA Authorizes First Robotically-Assisted Surgical Device for Performing Transvaginal Hysterectomy

The U.S. Food and Drug Administration has authorized marketing of the Hominis Surgical System, a new robotically-assisted surgical device (RASD) that can help facilitate...
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – MDCG 2019-11 Guidance on Qualification and Classification of Software in...

This document, which primarily targets medical software manufacturers, defines the criteria for the qualification of software falling within the scope of the new medical...
New guidance on biologics affects authorized generics

USA – Standalone at-home COVID-19 nasal swab kit receives EUA

A nasal swab kit that allows individuals to collect their own samples for COVID-19 diagnostic testing has been granted an emergency use authorization (EUA)...
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – MDCG’s 2020 Meetings to Tackle Clinical Data, Annex XVI, UDIs and More

As device firms ramp up their final preparations ahead of the 26 May application date for the Medical Devices Regulation (MDR), the European Commission’s...
WHO drafts guidance for pharma supply chain tracking

International – WHO Outlines Process to Designate Regulators as WHO-Listed Authorities

As part of a shift from the term “stringent regulatory authority” to “WHO-Listed Authority” (WLA), the World Health Organization (WHO) in May discussed some...
Australian regulatory action on breast implants and breast tissue expanders

Australia – TGA carves out exemptions for some software-based medical devices

Australia’s Therapeutic Goods Administration (TGA) has published the Therapeutic Goods (Excluded Goods) Amendment (Software-Based Products) Determination 2021, which will become effective on February 25, 2021....

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