USA – FDA concerned about potential device shortages due to new EtO limits

Rural and vulnerable populations could be placed at risk as the US Environmental Protection Agency (EPA) imposes new limits on the use of ethylene...

USA – FDA issues long-awaited device remanufacturing guidance

The US Food and Drug Administration (FDA) has published its final guidance on the remanufacturing of medical devices, adding a new section on regulatory...

USA – FDA publishes new dataset to aid medical device biocompatibility testing

The US Food and Drug Administration (FDA) has published a chemical dataset that analytical laboratories can use to demonstrate they can detect chemicals that...
ANVISA will implement new rules for medical device modifications in Brazil

Brazil – Brazil to recognize other agencies’ decisions on devices

In a step toward consolidating regulatory reliance, The Brazil Health Regulatory Agency (ANVISA) said on 8 April that it would recognize decisions by regulators...

USA – FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies

Today, the U.S. Food and Drug Administration authorized marketing of a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect...

USA – FDA criticized for approval of genetic test for opioid addiction risk

Physicians and public health advocates are urging the US Food and Drug Administration (FDA) to revoke its approval of AvertD to predict the potential...
Advice for Management of Clinical trials in relation to Coronavirus

UK – Regulation of devices in Northern Ireland

The​ Medicines and Healthcare products Regulatory Agency (MHRA) ​​​is​ the Competent Authority for medical devices and in vitro diagnostic (IVD) devices in Northern Ireland. This...

USA – Medical Device Development Tools (MDDT)

The FDA is announcing the qualification of a new tool through the Medical Device Development Tools (MDDT) program, marking the first-ever qualified database under...

USA – FDA proposes animal study requirements for dental bone grafts

The US Food and Drug Administration (FDA) on Thursday issued draft guidance for sponsors of dental bone grafting devices that offers advice on using...

USA – Device makers ask FDA for clarification, exceptions to metallic coating guidance

Medical device makers are asking the US Food and Drug Administration (FDA) to make exceptions to its recently proposed guidance on metallic and calcium...

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