Federal Register Notice: FDA is announcing the availability of proposed and final documents that have been prepared by Study Groups 1, 2, and 4 of the Global Harmonization Task Force that represent a harmonized proposal and recommendation from the groups that may be used by governments developing and updating their regulatory requirements for medical devices. Study Group 1 has developed a proposed document on the Role of Standards that provides guidance on the use of standards by a manufacturer when designing a medical device and subsequently when demonstrating the device conforms to relevant essential safety and performance criteria. Study Group 2’s document, “Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices,” provides guidance on the type of adverse events associated with medical devices that should be reported by a manufacturer to a national competent authority. Study Group 4 developed a document on Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers — Part 3: Regulatory Audit Reports that suggests a structure for audit reports used in multiple jurisdictions, promoting consistency and uniformity. To view this notice, click here.