The US Food and Drug Administration (Food and Drug Administration) referred to FDA, FDA is one of the implementing agencies in the US government established the Department of Health and Human Services (DHHS) and the Ministry of Public Health (PHS) in. As a scientific authority, FDA's role is to ensure that food, cosmetics, drugs, biologics, medical devices, and security of the American domestic production or import of radioactive products. It is one of the first federal agency to protect consumers as the main function. FDA registration and certification procedures for medical devices have a clear and strict definition, which is defined as follows: "The so-called medical equipment refers to the following conditions of the instrument, apparatus, tools, machinery, appliances, insert the tube, in vitro reagent, and other related items, including components, parts or accessories: specifically listed in the National Formulary or the Unite States Pharmacopeia or both of the above are in the appendix; intended use diagnostic animal or human disease, or other condition of the body in, or cure for diseases, mitigation and treatment persons; the expected impact of the animal or human body function or structure, but not via metabolism to achieve its primary purpose were. " Only meet the above definition of the product side is regarded as medical devices, under this definition, not only in the hospital a variety of instruments and tools, even though consumers can purchase glasses even in the general store boxes, glasses, toothbrushes and other fitness equipment and massage belong to the management of the FDA. It finds that domestic medical device is slightly different. Depending on the level of risk, FDA medical devices into three categories (Ⅰ, Ⅱ, Ⅲ), Ⅲ class highest risk level. FDA medical device will each have clearly defined their product classification and management requirements, FDA medical device product catalog has included more than 1,700 kinds of products. Any medical device you want to enter the US market, we must first understand the product classification and management application for listing requirements. FDA for medical devices developed a number of bills, changes and additions are not from time to time, but the underlying bill is not much, including: the Federal Food, Drug, and Cosmetic Act (FD & C Act, the fundamental Act); Public Health Service Act; fair package and identification of the bill; Health and Safety Radiation Control Act; Medical Devices Safety Act; Modernization Act. These bills, FDA gave a very detailed explanation and supporting a specific operating requirements. Business plan before entering the US market, the need to be carefully evaluated for their own regulations and specific requirements related to the product (including the different American product standards). In the clear after the above information, companies can begin to prepare the relevant dossier, according to certain procedures to obtain the approval of the FDA approved the declaration. For any product, companies are required to conduct business registration (Registration) and product listing (Listing). Ⅰ class products (accounting for about 47%), the implementation of the general control (General Control), most of the products simply register, column names and implementation of 高标准 standards, products can enter the US market (which is also a handful of product 高标准 exemption, a handful of products you need to submit to retain FDA 510 (K) application that PMN (Premarket Notification)); for Ⅱ products (accounting for about 46%), the implementation of the special control (Special Control), enterprises in the registration and After the column names, the need to implement 高标准 and submit 510 (K) application (few products are 510 (K) exemption); for Ⅲ products (accounting for about 7%), the implementation of the pre-marketing approval, registration and conducting business After the column names, the implementation of 高标准 shall submit to the FDA PMA (Premarket Application) application (Part Ⅲ products or PMN). Ⅰ class product, after companies submit relevant information to the FDA, FDA announcement only, no relevant documents issued to businesses; for Ⅱ, Ⅲ class equipment, companies are required to submit PMN or PMA, FDA announcement at the same time, will give enterprises formal market access approval letter (Clearance), which allows companies to own name in the US medical device market to sell their products directly. As to whether the application process to the corporate site 高标准 assessment, risk level according to the product by the FDA, regulatory requirements and market feedback and other comprehensive factors. Based on the above content shows that the vast majority of products during the business registration, product listing and implementation of 高标准, or re-submit a 510 (K) application, you can get FDA approval to market. 1.510 (K) file that is FDA required documents on the PMN, its corresponding FD & C Act section 510, it is usually called 510 (K) file. 2. substantive equality comparisons (SE) 3.510 (K) review process prior to the application must be clear whether the product is FDA recognized as a medical device, product categories, management requirements, apply a clear job content; the products listed on the application has access to the United States to force standard, the product meets the criteria (general requirements for official inspection reports testing organizations); in preparation 510 (K) application files, you need to consider whether it really needs to submit, submit, and when to submit the nature of which 510 (K) application : General 510 (K), Special 510 (K), to simplify the 510 (K); the issues raised by the application process FDA should promptly give written and timely answer; all data submitted to the FDA paper size should Letter Size (21.5cm X 29.7cm); all information submitted FDA enterprises need to leave the backup, because the FDA after the receipt of the application materials electronically scanned login, while the destruction of the application materials are not returned to the enterprise. For a small number of products, FDA will conduct on-site 高标准 enterprise assessment, companies need to reference the US 高标准 regulatory requirements, and with the right spot when the FDA review of 高标准 and businesses have a certain understanding of translators; the need to inform the FDA's formal contacts FDA regulations and procedures for a certain understanding, and can communicate directly with the FDA, in order to facilitate the timely feedback, companies can define their own or entrust advisory body responsible for daily communication with the FDA.