Will Medtech Rise to FDA's Sterilization Challenge?

USA – Will Medtech Rise to FDA’s Sterilization Challenge?

FDA issued two challenges Monday, both of which aim to address the environmental concerns surrounding the use of a gas called ethylene oxide to sterilize...
First FDA-Developed Medical Device Development Tool Receives Qualification

USA – First FDA-Developed Medical Device Development Tool Receives Qualification

A tissue mimicking material (TMM) for use in the preclinical development and evaluation of ultrasound medical devices became the first medical device development tool...
AdvaMed asks FDA to revise draft guidance on medtech inspections

USA – AdvaMed asks FDA to revise draft guidance on medtech inspections

In two comments submitted to US Food and Drug Administration (FDA) draft guidance on inspections of medical device establishments, AdvaMed recommended several changes. The draft...
Drug and medical device highlights 2018: Helping you maintain and improve your health

Canada – Drug and medical device highlights 2018: Helping you maintain and improve your...

The report gives information about new drugs and medical devices that Health Canada approved for sale in Canada, the information we published about potential...
US FDA issues final rule for appealing medical device regulatory decisions

USA – US FDA issues final rule for appealing medical device regulatory decisions

A final rule recently issued by the US Food and Drug Administration explains procedures and timeframe requirements whereby regulatory decisions by the agency’s Center...
Drug and medical device highlights 2018: Helping you maintain and improve your health

Canada – Pre‐market Requirements for Medical Device Cybersecurity : Guidance Document

This guidance document applies to products that consist of or contain software and are regulated as a medical device (Class I to Class IV) under...
FDA Revises 1999 Draft Guidance on Population Pharmacokinetics

USA – US FDA shakes up Medical Device Reporting Program

The US Food and Drug Administration’s medical device oversight division has ended reporting exemptions for some manufacturers and made more report data publicly available...
CDRH Finalizes Guidance on Diagnostic Ultrasound Systems and Transducers

USA – CDRH Finalizes Guidance on Diagnostic Ultrasound Systems and Transducers

In Wednesday’s final version of US Food and Drug Administration (FDA) guidance on the clearance of diagnostic ultrasound systems and transducers, FDA’s Center for...
CDRH Drafts Clinical Recommendations for Prostate Tissue Ablation Devices

USA – CDRH Drafts Clinical Recommendations for Prostate Tissue Ablation Devices

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) issued draft guidance Tuesday to support clinical testing of high-intensity...
Notified Body Survey Offers New Data on EU Medical Device Certificates

Europe – Notified Body Survey Offers New Data on EU Medical Device Certificates

Findings from a recent survey of notified bodies (NBs) for medical devices and in vitro diagnostics (IVDs) indicate fluctuation in the numbers of certificates in 2018...

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