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 application process 1.1. Enterprise registration a) Enterprise registration application form b) FDA confirms and publishes 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: