Today, the FDA issued a final guidance document titled General Wellness: Policy for Low-Risk Devices. The guidance explains that the FDA does not intend to actively regulate low-risk technologies that are…
Today, the FDA published the Adaptive Designs for Medical Device Clinical Studies Final Guidance. It provides clarity on how to plan and implement adaptive designs for clinical studies used in medical…
Today, the U.S. Food and Drug Administration released a draft guidance document, “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).” The Unique Device Identification System…
Today, the U.S. Food and Drug Administration released a draft guidance document, “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).” The Unique Device Identification System…
Today, the U.S. Food and Drug Administration is announcing the availability of the guidance titled “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Device.” This final…