Introduction to FDA

Introduction to FDA certification classification of medical devices
1、 According to the different risk levels, FDA classifies medical devices into three categories (I, II, III) with high risk level. FDA clearly defines the product classification and management requirements for each medical device. At present, there are more than 1700 kinds of FDA medical device product catalog. If any medical device wants to enter the U.S. market, it is necessary to first clarify the classification and management of the applied products Requirements, FDA approved Tel: i5o-i255-457o
1. Class I device: general control
As long as these devices are under general control, their efficacy and safety can be ensured. For example, crutches, spectacle lenses, adhesive tapes, etc., account for about 27% of all medical devices.
These Regulations include: forbidding the sale of rough products and improperly labeled products; forbidding the sale of unqualified products by FDA; reporting the hazards, repair, replacement and other matters related to FDA; restricting the sale, sale and use of certain equipment;
Implementation of GMP: domestic manufacturers, importers and sellers are required to register with FDA. Manufacturers shall list the products they manufacture. Class II and class III shall also comply with the above requirements.
2. Class II equipment: special controls
In addition to the above-mentioned general control, these products must meet the special requirements set by FDA or other industry recognized standards. These products include medical gloves, electric wheelchairs, hearing aids, sphygmomanometers, diagnostic catheters, etc., accounting for about 60% of all equipment. Among the special requirements of FDA, there are mandatory standards for specific products Standards), patient registration and post marketing supervision.
3. Class III equipment: pre marketing license
Generally speaking, the products of class III are mostly equipment for maintaining, supporting life or implanting into the body, which is potentially dangerous to patients and may cause injury or disease, such as heart rhythm regulator, intrauterine equipment and baby incubator, accounting for about 8% of all equipment. These devices must obtain FDA's PMA before they can be sold.
2、 FDA certification of medical devices includes:
The manufacturer shall submit the following materials for the label, technical transformation, customs clearance, registration and pre marketing report of the medical and health care devices of the FDA registered product listing registration (510 form registration) product listing review and approval (PMA review):
1. Five finished products with complete package;
2. Device structure drawing and text description;
3. Performance and working principle of the device;
4. Safety demonstration or test materials of the device;
5. Brief introduction of manufacturing process;
6. Clinical trial summary;
7. Product manual. If the device has radiation performance or releases radioactive substances, it must be described in detail.
3、 Reclassification of FDA certification of medical devices
The pre equipment is the equipment that was commercially released before May 28, 1976, i.e. the date when the medical device amendment of the federal food, drug and Cosmetic Act (FD & C act) was signed into law. These devices are initially classified as class I, class II or class III.
1. FDA may, on its own initiative or in response to a petition, reclassify a previously classified preamble device based on "new information," as described in section 513 (E) of the FD & C act. Information on the reclassification process under section 513 (E) of the FD & C act, including the number and type of equipment reclassified as part of this process from January 1, 2013.
2. Some of the preamendments device types were initially defined as class III through the 510 (k) plan, with the intention that FDA reclassifies them as class I or class II, or maintains class III classification and requires pre market approval (PMA) applications. In 2009, the FDA launched the 515 program initiative to complete the classification of class III preparatory equipment types that still require FDA final action.