Prothèses PIP : la Cour de cassation ordonne un nouveau procès pour le certificateur TÜV

France – Prothèses PIP : la Cour de cassation ordonne un nouveau procès pour...

C'est un nouveau rebondissement dans l'affaire des prothèses mammaires défectueuses de l'entreprise Poly Implant Prothèse (PIP). La Cour de cassation a ordonné aujourd'hui un nouveau procès...
A Look at the Competitive Landscape of Diabetes Devices

International – A Look at the Competitive Landscape of Diabetes Devices

Diabetes represents a huge market opportunity for medical device companies, but that also makes for a tough competitive landscape. Here we have reviewed the...
Updated: FDA Warns Zimmer Biomet’s Indiana Plant

USA – Updated: FDA Warns Zimmer Biomet’s Indiana Plant

Zimmer Biomet announced Friday via an SEC filing that it received a warning letter related to observed non-conformities with current good manufacturing practice (CGMP) requirements of...
CDRH Classifies Respiratory Infection IVD, System for Neurological and Psychiatric Disorders

USA – FDA proposes exempting some flow cytometers from 510(k) requirements

The Food and Drug Administration (FDA or Agency) is announcing its intention to exempt certain flow cytometer instruments from premarket notification requirements, subject to...
Biosimilar use may increase with scrutiny of high drug prices

USA – US Regulators Update Policies for Medical Device Voluntary Consensus Standards

EMERGO SUMMARY OF KEY POINTS: US FDA draft guidance explains agency’s process for recognizing voluntary consensus standards used for medical device declarations of conformity. ...
Publication de la norme ISO 11930:2019 sur l'évaluation de la protection antimicrobienne d'un produit cosmétique

International – Insights on Upcoming Revisions to ISO 13485

Following the new outcome meeting statement posted Monday by the management committee of the International Medical Device Regulators Forum (IMDRF), Focus obtained insights into upcoming revisions...
Hairy Coating Keeps Nanoparticles Safe from Immune System, Liver

USA – Hairy Coating Keeps Nanoparticles Safe from Immune System, Liver

Nanoparticles are seemingly a great way to treat tumors, but they’re so rapidly washed out by the bloodstream that few of the nanoparticles actually...
US FDA Modifies List of Recognized Standards for Medical Device Premarket Reviews

USA – FDA Modifies List of Recognized Standards for Medical Device Premarket Reviews

EMERGO SUMMARY OF KEY POINTS: US FDA has updated its list of Recognized Consensus Standards for use in medical device premarket submissions. FDA’s latest...
Gottlieb to Resign as FDA Commissioner

USA – Gottlieb to Resign as FDA Commissioner

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb unexpectedly announced Tuesday that he will resign in one month. In his resignation letter (read it...
FDA suggests letting more patients with viral infections into cancer clinical trials

USA – FDA issues draft guidance on non-binding feedback on inspections

The FDA has issued draft guidance for medical device makers on how to request nonbinding feedback on certain kinds of Form 483 deficiencies noted during on-site...

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