The U.S. Food and Drug Administration (FDA) 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 regulatory agency, FDA is responsible for ensuring the safety of food, cosmetics, drugs, biological agents, medical equipment and radioactive products produced or imported in the United States. It was one of the first federal agencies whose main function was to protect consumers

FDA certification classification:

FDA registration

Cosmetics FDA

Medical device FDA

Laser FDA

Standard and grade of American masks

NIOSH standard classifies the filter screen material and filtration efficiency of masks, which is highly recognized all over the world. According to the material of the filter screen in the middle layer of the mask, it is divided into three types: n, R and 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 mask is a kind of mask with filtration efficiency ≥ 95% in N series; R. P is used to protect non oily and oily suspended particles. Compared with R series, P series is used for a relatively long time.

Astmf2100 standard is a medical standard, which 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 mask; Level3 mask can be used in the operating room, also known as surgical mask.

FDA certification process of masks

Step 1: determine the U.S. agent and medical device classification

Step 2: choose the right pre listing submission

Step 3: prepare appropriate materials for submission before listing

Step 4: the enterprise pays the official annuity to FDA

Step 5: submit pre marketing materials to FDA

Step 6: complete enterprise registration and device listing