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Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
To establish a reference range, the Clinical and Laboratory Standards Institute (CLSI) recommends testing at least 120 patient samples. In contrast, for the verification of a reference range, it is recommended to use a total of 40 samples, 20 from healthy men and 20 from healthy women, and the results should be compared to the published reference range.
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
It defines terms relating to fees for medical devices. "30-day notice" is defined as a notice of a supplement to an approved application that is limited to a request to make modifications to manufacturing procedures or methods affecting the safety and effectiveness of the device.
An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study [1]) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). [2]
Oversee the Notified Bodies that ensure medical device manufacturers comply with regulatory requirements before putting devices on the market. Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed products.
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability. It does not address clinical decision-making related to use of the device. The standard will replace ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability.