Medical Device Safety, Performance Document

The International Medical Device Regulators Forum, which includes FDA, has issued a proposed document, “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices,” to harmonize the documentation and procedures that are used to assess whether a medical device conforms to the regulations that apply in each jurisdiction. “The worldwide adoption of fundamental design and manufacturing requirements for medical devices that, when met, provide assurance the device is safe and performs as intended offers significant benefits to the manufacturer, user, patient, or consumer, and to regulatory authorities,” the document says. “Eliminating differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.”

The document supersedes a 2012 version produced under the Global Harmonization Task Force.