FDA

The U.S. Food and Drug Administration (Food and Drug Administration) is referred to as FDA . 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. It is one of the earliest federal agencies whose main function is to protect consumers.
FDA certification classification :
food FDA registration,
cosmetics, FDA,
medical devices, FDA,
laser, FDA
 , and the standards and grades of masks in the United States.
 NIOSH standards classify the filter material and filtration efficiency of masks. , The standard is highly recognized worldwide. According to the filter material of the middle layer of the mask, there are three types: N, R, P series, N is used to protect non-oily suspended particles (usually non-oily particles refer to coal dust, cement dust, acid mist, microorganisms, etc.), N95 masks It is a type of mask with a filtration efficiency of ≥95% in the N series; R and P are used to protect against non-oily and oily suspended particles. Compared with the R series, the P series have a relatively long use time.
 The ASTMF2100 standard is a medical standard that divides masks into three levels: low protection (Level1), medium protection (Level2) and high protection (Level3). The higher the level, the better the protection performance. Level1 and Level2 masks are usually called procedure masks; Level3 masks can be used in the operating room and are also called surgical masks.
 Mask FDA certification process
 Step 1: Determine the US agent and medical device classification
Step 2: Choose the correct pre-market submission
Step 3: Prepare appropriate materials for the pre-market submission
Step 4: The company pays the official annuity to the US FDA
Step 5: Change Submit pre-marketing materials to the FDA
Step 6: Complete company registration and device listing
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