Release date: 2008-03-24 US FDA's performance standards for medical equipment and pre-market approval. According to the US Code of Federal Regulations, Class I, Class II, and Class III medical devices are subject to the general regulatory requirements for medical devices (including business registration, product registration, GMP requirements, labeling requirements and pre-market notifications). For Class II and III devices that rely solely on general management to ensure the safety and effectiveness of power wheelchairs, infusion pumps, surgical drapes, etc., special management measures such as mandatory performance standards are required. Class III medical devices are the most severely managed medical devices, some of which are used to support and extend human life, or have important protective effects on human health, or have a large potential risk, such as heart valve replacement devices, breasts. Filled with silicone, implanted cerebellar stimulator, etc. Such medical devices usually require pre-market approval (PMA) to be submitted to the FDA prior to marketing to ensure that they are safe and effective through scientific assessment. Ganoherb International Inc. , http://www.ganoherb.us
Enforcing performance standards requires enforcement of performance standards that include: (1) performance characteristics of medical devices; (2) design, structure, composition, and properties of medical devices, and their compatibility with power systems, other devices, etc. (3) Suitable for the manufacturing method and quality control procedure of medical devices; (4) Inspection methods, by the manufacturer for sampling or full inspection of medical devices, and for inspection by FDA or third parties; (5) Publication of inspection results (6) The manufacturer submits to the buyer or the FDA a certificate that the medical device meets the corresponding performance standards; (7) the regulations on the sales and circulation of the medical device; and (8) the form, content and use of the label.
Pre-market approval Pre-market approval refers to the FDA's scientific review of the safety and efficacy of Class III medical devices. The FDA believes that the safety and effectiveness of Class III medical devices are not guaranteed by general management and enforcement of performance standards. According to Section 515 of the Federal Food, Drug, and Cosmetic Act, Class III medical devices must be approved by the FDA prior to marketing.
Pre-market approval is the most stringent FDA-requested application for medical device listing. Only when the FDA considers that the pre-market approval application contains sufficient and valid scientific evidence to ensure the safety and effectiveness of the medical device, the pre-market approval application will be approved. The FDA's pre-market approval review time is at least 180 days. Pre-market approval application materials must be written on a scientific basis, for example, must have valid clinical data, scientific analysis and evidence, otherwise it will delay the FDA review cycle for the medical device and the FDA's approval. ——Shanghai Medical Device Industry Association