L FDA certifies the Food and Drug Administration (FDA) as one of the executive agencies established by the U.S. government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific regulator, FDA's responsibility is to ensure the safety of food, cosmetics, drugs, biological agents, medical equipment and radiological products produced or imported by the United States. It was one of the earliest federal agencies whose main function was to protect consumers. 1. FDA certification of laser products can be done according to categories. The same kind of products can be done together, mainly depending on wavelength, angle range of wave, current, voltage and light path. The specifications of laser head can be classified according to the danger degree of laser to human body, and the MPE (maximum possible effect of observation on eyes) can be benchmarked in light tree, which can be divided into one to four levels. Laser manufacturers should attach warning labels of Class II, III and IV to the corresponding laser products. Class I: Low output laser (power less than 0.4 mW) will not exceed the MPE value for eyes and skin under any conditions, even after focusing through optical system. It can ensure the safety of design without special management. Typical applications include laser pointer, CD player, CD-ROM equipment, geological exploration equipment and laboratory analytical instruments. Class II: Visual laser with low output (power 0.4 mW-1 mW), the reaction time of closing eyes is 0.25 seconds, and the exposure can not exceed the MPE value. Usually the laser below 1 mW will cause dizziness and unable to think. It can not be completely safe to close the eyes. It is not necessary to observe directly in the beam, nor to irradiate other people's eyes directly with Class II laser, so as to avoid observing Class II laser with long-range equipment. Typical applications such as classroom demonstration, laser pointer, aiming equipment and range finder, etc. Class III: Mid-output laser, if the beam directly into the eye, will cause harm, for some safety reasons, further divided into IIIA and IIIB. Class IIIA is a continuous-wave laser with visible light output of 1-5mW. The energy density of the laser beam should not exceed 25W/m?? M. It is possible to avoid the danger of observing IIIA laser with long-range equipment. The typical application of IIIA has many similarities with Class II, such as laser pointer, laser scanner, etc. Class III B CW laser is 5-500 mW. It is dangerous to observe directly in the beam. But the minimum irradiation distance is 13 cm and the maximum irradiation time is less than 10 seconds. Typical applications of IIIB lasers include spectroscopy and entertainment lighting. ClassIV: High output CW laser (greater than 500 mW), higher than the third level, has the risk of fire, and diffuse reflection is also dangerous. Typical applications include surgery, research, cutting, welding and micromachining. 2. Center for Food Safety and Practical Nutrition (CFSAN): This center is the most workload Department of FDA. It is responsible for food safety throughout the United States except meat, poultry and eggs under the jurisdiction of the United States Department of Agriculture. Although the United States has the safest food supply in the world, about 76 million foodborne diseases occur every year, 325,000 people need hospitalization for foodborne diseases and about 5,000 people die from foodborne diseases. The Center for Food Safety and Nutrition is committed to reducing foodborne diseases and promoting food safety. And promote various plans, such as the promotion and implementation of HACCP plan. Its functions include: ensuring the safety of substances and pigments added to food; ensuring the safety of food and ingredients developed through biotechnology; managing activities related to the correct identification of foods (such as ingredients, nutritional health statements) and cosmetics; formulating policies and regulations to regulate dietary supplements, infant food formulations and medical foods; and ensuring cosmetics. Safety of ingredients and products to ensure correct labeling; supervision and regulation of food industry after-sales behavior; consumer education and behavior development; cooperation projects with state and local governments; coordination of international food standards and safety. 3. Drug Assessment and Research Center (CDER): The center aims to ensure the safety and effectiveness of prescription and non-prescription medicines by evaluating them before they are marketed and supervising over 10,000 medicines sold on the market to ensure that products meet the constantly updated highest standards. It also monitors the authenticity of advertisements for drugs on television, radio and publications. Drugs should be strictly monitored to provide consumers with accurate and safe information. 4. Equipment Safety and Radiation Protection Health Center (CDRH): The center is ensuring the safety and effectiveness of new medical devices. Because more than 20,000 companies around the world produce more than 80,000 kinds of medical devices, ranging from blood sugar monitors to artificial heart valves. These products are closely related to people's lives, so the center also supervises after-sales services nationwide. For radiation-producing products such as microwave ovens, televisions and mobile phones, the center has also established some corresponding safety standards. 5. Center for Biological Product Assessment and Research (CBER): The CBER supervises biological products that can prevent and treat diseases, so it is more complex than chemical comprehensive drugs. It includes scientific research on the safety and efficacy of blood, plasma, vaccines, etc. 1. FDA certification procedure and its requirements 1. FDA certification procedure and its requirements 1. FDA application process 1.1. Enterprise registration a) Enterprise registration application form b) FDA confirmation and issuance of enterprise serial number; 1.2. Product registration 1.2.1 medical device products are classified into three categories according to the degree of safety risk: a) Class 1 medical device listing control b) Class 2 market access approval (510 (K) approval) c) Class 3 PMA approval before entering the market 1.2.2 Principal Agent "FDA Registration and Communication" Entrustment Agreement (signed by the representative of the legal person and affixed with the company seal) 1.2.3 Provides information a) Business License of the legal person of the enterprise b) Code Certificate of the legal person of the enterprise, Registration Certificate of the legal person of the association, etc. (Duplicate and affixed with the company seal) Certificate of Qualification or Production License (duplicate and affixed with the company seal) d with the Application Form for FDA Registration (one in Chinese and one in English, affixed with the company seal) e of FDA Addition of additional documents (if any) required to be submitted. F) Brief introduction of the enterprise (time of establishment, economic performance, technical strength, main production varieties, performance and asset status of the enterprise). 1.3 Payment registration and listing are free; 510 (K) and PMA are required to pay according to the fee standards published by FDA online. 1.4 After processing the registration fee, FDA completes the registration in 60 working days; 1.5 FDA website announces the registration status, 510 (K), PMA FDA sends another approval letter. 2. Medical Device 510 (K) Application Document 2.1 Medical Device 510 (K) Document, also known as FDA Document for PMN, is usually referred to as 510 (K) Document because of its corresponding FD&C Act Section 510 (K). The FDA has a basic requirement for the information that must be included in 510 (K) documents. Its contents are as follows: 1) Application Letter, 2) Catalogue, 3) Authenticity Guarantee Statement, 4) Equipment Name, 5) Registration Number, 6) Classification, 7) Performance Standard, 8) Product Identification, including Enterprise Packaging Identification, Use Instructions, Packaging Accessories, Product Identification, etc. 。  9) Substantive Equivalence Comparison (SE) 10) 510 (K) Summary or Statement 11) Product description, including expected use, working principle, power source, components, photographs, process drawings, assembly drawings, structural sketches, etc. 12) Safety and effectiveness of products, including various design, test data 13) biocompatibility 14) Pigment additives (if applicable) 15 software Validation (if applicable) 16 Sterilization, including description of sterilization methods, sterilization verification, product packaging and labeling, 2.2 homogeneity comparison (SE)a) homogeneity comparison is to prove that the products applied for listing are substantially equivalent in terms of safety and effectiveness to those legally sold in the United States market. B) Selecting suitable products for comparison is a key step in 510 (K) application. When comparing, we should consider the following aspects: c) Enterprises must provide sufficient information to prove that the listed and compared instruments are substantially equal (SE), otherwise 510 (K) applications will not pass. 2.3 510 (K) Examination Procedure a) After receiving the 510 (K) information submitted by the enterprise, FDA first checks whether the information is complete. If the information is complete, it accepts and sends confirmation to the enterprise. At the same time, it gives the application acceptance number (KYXXXX), which will also be used as the number after formal approval. If not, it requires the enterprise to supplement the information within the prescribed time, otherwise the enterprise will give up. Handle. B) The FDA enters the internal working procedure immediately after accepting the application, which may also require additional information from the enterprise. C) After the 510 (K) application has been examined, the FDA does not issue approval letter immediately. Instead, it determines whether to conduct on-site GMP assessment according to the product risk level and whether the market has adverse reactions to the enterprise before, and then sends the formal approval letter (Clearance) to the enterprise after the assessment is passed. d) If there is no need for on-site GMP assessment, 510 (K) application will be sent to the formal approval letter immediately after its approval. Pieces. 3. The PMA Act (515) stipulates that all medical devices that are not as effective or safe as those already on the market in 1976 must undergo a pre-market Approval (PMA) review procedure. These new or improved devices are all classified as Class III until they have been approved for the market and then re-classified. Some of them are adjusted to Class because of their low risk. I or Class II can apply for listing after 510 (k) procedure. However, after the signing of the FDA Modernization Act by the incumbent President of the United States, new medical devices that are not substantially equivalent to those currently legally available on the market may not necessarily be classified as Class II I or Class II, but may also be classified as Class I or Class II, and apply for pre-listing notification permission following the 510 (k) procedure. At present, most of the equipment belonging to Class III are products to support or maintain the life of patients, or those who have a significant impact on human health. Their side effects may lead to illness or injury. All such equipment must obtain FDA's marketing license before it can be sold. The application documents of PMA are to prove the safety and efficacy of the equipment. The application documents of PMA need not be compared with the existing products on the market, but more complete and rigorous supporting information must be presented. In short, the focus of PMA review includes product description, materials used in manufacturing process, pre-clinical laboratory and animal test results, clinical test results based on native races, labels and instructions for use.