|
V/M |
SAFETY
|
EMC |
RADIO
|
ENGRGY EFFICIENCY
|
|
M |
Y |
Y |
Y |
N |
The US Food and Drug Administration (Food and Drug Administration) is referred to as FDA. The FDA is 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 management agency, the FDA's responsibility is to ensure the safety of food, cosmetics, drugs, biological agents, medical equipment, and radiological products produced or imported in the United States. Internationally, the FDA is recognized as one of the largest food and drug regulatory agencies in the world.
Food and Drug Administration (FDA) Supervisor: Supervision and inspection of food, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal food and drugs, wine beverages with an alcohol content of less than 7%, and electronic products; also cosmetics , Radiation products, combination products and other electronic products and medical products related to personal health and safety. The testing, inspection and certification of the ionic and non-ionic radiation generated during the use or consumption of the product that affect human health and safety. According to regulations, the above-mentioned products must be inspected by the FDA to be safe before they can be sold on the market. The FDA has the right to inspect manufacturers and prosecute offenders.
1. Medical devices distributed in the United States are subject to general control, pre-market and post-market regulatory control.
2. Most Class I devices do not need to perform the 510(k) pre-market notification obligation. Manufacturers need to complete business registration and list their devices in the database.
3. Most Class II devices, and some Class I and Class III medical devices that require customs clearance to enter the US market can only be allowed to enter the US market through the pre-market notification procedure 510(k).
4. Most Class III devices usually require pre-market certification (PMA).
5. The manufacturer must comply with 21 CFR Part 820 of the "Quality System Regulations".
6, After obtaining the product certification (PMA) or 510(k) customs clearance, the FDA can conduct on-site inspections at any time to verify whether the manufacturer complies with the quality system regulations. This usually includes management, development, corrective and preventive measures, and production process control.
Required documents when apply FDA certification
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