According to FDA, a new approval path will be introduced in 2019 to replace 510 (k) in order to promote the integration of medical devices with the modern world and be safe and effective. The 42-year-old FDA medical device approval path is due to be reformed in 2019, putting continued pressure on Chinese exports.
510(k) is a pre-market application document submitted to FDA to prove that the devices applied to market are as safe and effective as legally marketed devices that are not affected by pre-market approval. Applicants are required to compare the devices on the market with one or more similar devices available in the United States, and to draw and support the conclusion of the equivalent device. Approval path reform is due to the 510 (k) has been a number of security vulnerabilities. The 510 (k) code currently in use was originally established in the 1976 Medical Devices Amendment Act and amended in the 1990 safe Medical Devices Act.
Break the vicious circle
FDA said in a statement that between 2015 and 2018, 20 percent of the products approved by 510 (k) were compared with older products that had been approved for more than 10 years, and earlier devices were approved on the basis of earlier devices. As a result, the approved devices do not represent the current rapid development and improvement of medical equipment and current clinical standards. (k) is not for all medical devices. FDA classifies medical devices into IHII III, with different reporting procedures for each category. Most of the products in Class I are exempted from the pre-market notification procedure. A small number of products in the II class are exempted from the pre-market notification procedure. Most of the products are required to be pre-market notices (510K). Category III is a product with greater danger or harmfulness, or used to support and maintain life, and a pre-market approval system is implemented. Experiments are conducted in humans and all data are compiled and submitted to FDA scientists for review. Most of the pre-market medical device applications FDA receives each year are 510 (k), in 2017 alone. The Center for device Safety and radiation Protection Health approved 3173 products through the 510 (k) process, accounting for 82% of all medical devices approved. Compared with old products, some medical devices which are not fully tested but have hidden safety problems may enter the market. The British Medical Journal earlier published an international survey of implanted medical devices showing that more than 5.4 million adverse events have been reported to the FDA over the past decade. Although regulators, manufacturers and doctors ensure that the devices are safe, the device is damaged, invalidated, corroded, ruptured or broken after the patient has implanted or used it. Over the past decade, 1.7 million people have been injured and nearly 83000 people have been killed. Nearly 500000 reports have linked the removal of internal instruments to adverse events. Some implants that failed to test in baboons can also be marketed, even if they have been tested directly on pigs or cadavers. The FDA has been aware of the safety implications of the (k) 's review of a large number of medical devices that have been removed in recent years since the 1976 Medical device Amendment Act, including 1,477 since 2012. The revision will focus on the use of newer similar equipment comparisons, the elimination of older and older similar devices, and the improvement of the 510 (k) safety and performance standard assessment approach. The report says FDA will promote the use of newer comparisons of similar devices, hoping to push manufacturers of medical devices to develop new products based on equipment that has been studied for no more than 10 years. A list of equipment that has proved to be approved through material equivalence with old equipment will be posted on its website.
Export enterprise pressure
With the development of China's medical device industry, Made in China medical devices appear more and more frequently in the United States. China's exports of medical devices totaled US $21.703 billion in 2017, up 5.84% from a year earlier, according to China's customs statistics. Exports to the United States were $5.838 billion, up 5.08 percent from the same period last year. The United States became China's largest exporter of medical devices. The path to a full replacement of 510 (k) will pose greater challenges for Chinese medical device companies that will apply for certification. "it will only be more difficult, there is no simple reason." Shanghai involves the medical device export business company to the reporter bluntly. Relevant industry personnel said: "after the reform, export difficulty is inevitable." Whether it's product technical data or clinical evaluation data, because the product can only refer to the latest, it is relatively difficult to find the comparative data. If we use the old and old data again, it will be very difficult to pass the comparison. " "the FDA approval process will be more stringent, and the challenge will be greater for Chinese medical device manufacturers who intend to use the United States as an export destination," the source said. "most of the manufacturers of medical devices in China basically produce basic or electronic devices. Previous products can only meet the requirements of the standard. If the standards are raised after the reform, it may not only require the characters, but also the quality to meet the requirements," he said. For example, requiring the use of special steel or special software, "people in the relevant industries said." the production standards of many medical devices in China are now very low. For example, some transfusion products, if required to be decomposable, cannot pollute the environment. Many Chinese products are not qualified. " In addition, for China's medical device market, there is still a gap between the technical level and foreign countries. Foreign countries have rich experience in the research and development of high-end medical devices, with advantages of capital and brand, advanced technology, concentration of talents, monopoly of many key technologies. China's medical device industry will face greater competitive pressure. Referring to the way out for Chinese medical device companies, people concerned said, "We still have to rely on research and development. Once standards are raised, it is very difficult to meet the requirements." At present, many R & D technologies are in the hands of foreign countries. Many electronic medical devices in China cannot be produced even with core components. Some enterprises are assembly companies. The future development path of Chinese medical devices is to go to the high end. "