FDA has a clear and rigorous definition of medical devices and is defined as follows: "Medical devices refer to instruments, devices, tools, machinery, appliances, insertion pipes, in vitro reagents and other related articles that meet the following conditions, including components, parts or Attachment: Incidentally listed in National Formulary or the Unite States Pharmacopeia or both of the appendix; is expected to be used in the diagnosis of animal or human disease, or other physical condition, or for the healing, mitigation and treatment of the disease; Animal or human body function or structure, but not by metabolism to achieve its main purpose. "
Only in line with the above definition of the product side is seen as medical equipment, in this definition, not only the hospital a variety of instruments and tools, even with consumers in the general store to buy glasses frames, glasses, toothbrush and massage equipment and other fitness equipment And so belong to the management of the FDA. It is slightly different from the domestic identification of medical devices.
According to the different levels of risk, FDA will be divided into three categories of medical devices (Ⅰ, Ⅱ, Ⅲ), Ⅲ class of the highest risk level. FDA will clearly specify its product classification and management requirements for each medical device. Any kind of medical device you want to enter the US market, you must first understand the application for listing product classification and management requirements.
The FDA has enacted a number of bills for medical devices that are modified and supplemented from time to time, but there are not many fundamental bills, including the Federal Food, Drug, and Cosmetic Act (FD & C Act); the Public Health Service Act; And the Act of Identity Act; Health and Safety Radiation Control Act; Safety Medical Device Act; Modernization Act. For these bills, the FDA gave a very detailed explanation, and supporting the specific operational requirements. Before planning to enter the US market, companies need to carefully evaluate the regulations and specific requirements (including different US product standards) for their own products.
After clarifying the above information, the enterprise can proceed to prepare the relevant application materials and report to the FDA according to certain procedures to obtain approval approval. For any product, companies need to register (Registration) and product listing (Listing). For Class I products (about 47%), the implementation of the general control (General Control), the vast majority of products only need to register, list and implement the GMP specification, the product can enter the US market (of which a small number of products with GMP (About 46%), the implementation of the special control (Special Control), the enterprise is engaged in the registration and (About 7%), the implementation of the pre-market license, the enterprise is engaged in the registration and / or the application of the GMP and the submission of 510 (K) applications (very few products are 510 (K) exemption) After listing, the GMP should be implemented and submitted to the FDA for the PMA (Premarket Application) application (part of the Class III product or PMN).
The FDA shall submit the PMN or PMA to the enterprises of Class II and III, and the FDA shall, at the same time as the announcement, give the enterprise with the relevant information, Formal market access approval letter (Clearance), which allows enterprises to their own name in the US medical device market directly sell their products. As for the application process to the enterprise on-site GMP assessment, by the FDA according to product risk level, management requirements and market feedback and other comprehensive factors.
The above content can be seen that the vast majority of products in the enterprise registration, product listing and implementation of GMP, or submit a 510 (K) application, you can get FDA approval to market.
1.510 (K) file is also required by the FDA for the PMN file, due to its corresponding FD & C Act Section 510, it is usually called 510 (K) file.
2. Substantial Equivalence Comparison (SE)
3.510 (K) review procedures
Before the application must be clear whether the product was FDA recognized as medical equipment, product categories, management requirements, a clear application for the content;
On the application of listed products to check whether the United States mandatory standards, whether the product meets the standard (the general requirements of the inspection body of the formal inspection report);
510 (K), special 510 (K), simplified 510 (K), 510 (K), 510 (K), 510 (K), 510 (K), 510 (K), 510 (K), 510 (K), 510 (K), 510 (K) ;
The application process in the FDA's questions should be promptly given a written, timely answer;
All paper sizes submitted to FDA should be Letter Size (21.5cm x 29.7cm);
All FDA data companies need to leave a backup, because the FDA received the application information after the electronic scan login, while the destruction of application information, not returned to the enterprise.
For a small number of products, FDA will conduct on-site GMP assessment of enterprises, companies need to refer to the US GMP management requirements, and FDA on-site audit with the appropriate, GMP and enterprises have a certain understanding of the translators;
Inform the FDA's official contact to have a certain understanding of the FDA regulations and work procedures, and can communicate directly with the FDA to facilitate timely feedback, companies can clearly or commission the advisory body responsible for the daily communication with the FDA.