USA – FDA releases draft guidance on use-related risk analysis for combo products
The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for...
USA – FDA drafts guidance on essential outputs for drug delivery devices
The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors of drug-device combination products in developing “essential drug delivery...
USA – Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological...
This guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of...
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...
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...
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...
