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Today, the U.S. Food and Drug Administration released a draft guidance document, “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.”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…
Today the FDA issued a final order to reclassify external pacemaker pulse generator (EPPG) devices. An EPPG is a device used with cardiac pacing leads and temporarily worn outside of the body…
Today the FDA is sharing an interactive tool for mobile health app developers created by the Federal Trade Commission (FTC) in collaboration with the FDA, the Office of the National Coordinator for…
The FDA has added new information on our webpages about adverse event reporting requirements. The Electronic Medical Device Reporting (eMDR) System webpages help manufacturers, importers and health care facilities understand eMDR requirements…
On March 16, 2016, the FDA posted an updated version of the Sterility Final Guidance, originally published as final on January 21, 2016. The guidance was updated to correct an inadvertent…
Today, the U.S. Food and Drug Administration issued final guidance document, “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” . Its recommendations seek to…