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Today we released the “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” draft guidance, which provides recommendations to improve the quality, consistency and transparency…
Today we issued the final guidance document Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.” This final…
Today, the U.S. Food and Drug Administration released a draft guidance document, “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.” The purpose of this…
Today the Food and Drug Administration (FDA) issued a final rule “Use of Symbols in Labeling” allowing the use of stand-alone symbols in medical device labeling, without adjacent explanatory text. The final…
Dear Modular PMA Holder:We are writing to inform you that effective June 13, 2016, FDA’s Center for Devices and Radiological Heath (CDRH) has implemented several process changes involving Modular PMAs. …
On May 16, 2016, we issued the final guidance document Postmarket Surveillance Under Section 522 of the Food, Drug, and Cosmetic Act. Section 522 of the Federal, Food, Drug and Cosmetic Act…