ANVISA: Nearly half of all Brazil GMP certificates now issued under Medical Device Single Audit Program

Brazil – Brazil’s new UDI requirements for medical devices: Compliance implications for manufacturers

Brazilian medical device market regulator ANVISA has rolled out its proposed framework for Unique Device Identification (UDI) requirements, and is seeking public comment on...

USA – CDRH official offers advice for smoother Q-submission meetings

A policy analyst with the US Food and Drug Administration (FDA) walked through mechanisms the medical device industry can use to request pre-submission meetings,...
New guidance on biologics affects authorized generics

USA – FDA seeks expanded authority to boost device supply chain

FDA has called for new powers and more funding to improve its ability to prevent medical device shortages. Janet Woodcock, the acting FDA commissioner, said...
New guidance on biologics affects authorized generics

USA – FDA finalizes long-awaited UDI guidance

The US Food and Drug Administration (FDA) on Tuesday finalized its guidance on the form and content requirements for unique device identifiers (UDI), nearly...

USA – US FDA revokes Emergency Use Authorizations (EUA) for some personal protective equipment...

The US Food and Drug Administration (FDA) has closed coronavirus pandemic-related emergency market access routes for some disposable respirator devices and personal protective equipment...

USA – FDA report examines use of patient experience data in decision-making

The US Food and Drug Administration (FDA) has published its first report on how it uses patient experience data in regulatory decision-making. As part of...

USA – US FDA aims to improve cybersecurity related to servicing and maintenance of...

A new discussion paper published by the US Food and Drug Administration focused on cybersecurity risk and vulnerability issues directly related to servicing medical...

USA – FDA explains when device ‘servicing’ becomes ‘remanufacturing’

At what point does manipulation or repair of a medical device cross the line from “servicing” to “remanufacturing?” A new draft guidance from the...

USA – Testing for Biotin Interference in In Vitro Diagnostic Devices

The Food the Drug Administration (FDA or we) is providing recommendations on the testing for interference by biotin on the performance of in vitro...

USA – FDA authorizes new device to help diagnose pediatric autism

The US Food and Drug Administration on 2 June authorized the marketing of a first-of-its kind device intended to help diagnose autism spectrum disorder...

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