The supervision mode of category I products is "general control", and the specific provisions are as follows:
1 enterprise registration or registration, including the registration of various production sites;
List the instruments that have entered the market;
3. Submit a "pre-marketing notice" (510 (k)) before selling new equipment or equipment that has undergone major modification;
4. The production process should comply with GMP regulations;
5 notification and maintenance;
6. It is forbidden to shoddy, mislabel and restrict the use of medical devices;
7 records and reports.
The supervision mode of the second category of products is "special control". In addition to the requirements of "general control", the applicant shall also provide the officially promulgated standards, post-marketing monitoring documents, efficacy feedback registration, special labeling requirements, pre-marketing (clinical trials) clinical research reports (including clinical and non-clinical studies) and guidance documents. FDA implements pre-marketing registration for such products, requiring manufacturers to apply to FDA 90 days before marketing. The US Food and Drug Administration checks whether the product is basically equivalent to the listed product. After passing the examination of 5 10(k), the product can be sold in the market.
The supervision mode of Class III products is "pre-listing approval". The third category of products must go through the "pre-marketing approval" (PMA) procedure before they are allowed to enter the market. In addition to meeting the requirements of "general control", it is also necessary to submit documents proving the expected medical effect, as well as animal experiments and clinical research reports on microbiology, toxicity, immunity, biocompatibility and shelf life. Before the product goes on the market, the manufacturer must submit the PMA application and related materials to FDA to prove that the product quality meets the requirements and the clinical use is safe and effective. The FDA will inform the manufacturer whether to file a case for review within 45 days after receiving the PMA application, and make a decision on whether to approve it within 180 days.
According to the types of documents submitted, the ways for medical devices to enter the American market can be divided into: 5 10(k) exemption; 5 10(k)； PMA .
5 10(k) exemption refers to products with a footnote (*) in the federally registered category I product catalogue. At present, most I and II products can be exempted from 5 10(k).
5 10(k), that is, the pre-marketing notice, is intended to prove that the product is essentially equivalent to the legally listed product. The meaning of substantial equivalence: the same as the intended use of the listed product; New functions of products will not affect safety or effectiveness, or new functions that affect safety and effectiveness have acceptable scientific methods to evaluate the impact of new technologies, and there is evidence that these new technologies will not reduce safety or effectiveness.
PMA refers to pre-marketing approval, which is intended to provide sufficient and effective evidence to prove that medical devices can ensure the safety and effectiveness of products according to the intended use of design and production.