Today, the U.S. Food and Drug Administration updated the Expedited Access Pathway Program website with two Data Development Plan examples that serve as a resource for sponsors. In April 2015, the FDA…
Today, the U.S. Food and Drug Administration (FDA) released a draft guidance document entitled “510(k) Third Party Review Program.” The purpose of this draft guidance is to explain the FDA’s…
Today the FDA released two draft guidance documents: “Deciding When to Submit a 510(k) for a Change to an Existing Device,” which applies to medical device changes broadly, and “Deciding…
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Today, the U.S. Food and Drug Administration released a draft guidance document, “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).”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Today, the U.S. Food and Drug Administration released a draft guidance document, “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).”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…
Today the FDA published a final guidance, which provides a framework to consider extrapolating existing data to evaluate a device’s performance in pediatric patients in pre-market approval applications (PMAs), humanitarian device…
Today we released the “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” draft guidance, which provides recommendations to improve the quality, consistency and transparency…