Applicable products


The center is the FDA’s largest department. It is responsible for food safety throughout the United States, except for meat, poultry and eggs under the jurisdiction of the U.S. Department of agriculture. Although the United States has the safest food supply in the world, there are about 76 million foodborne diseases every year, 325000 people need to be hospitalized for foodborne diseases, and about 5000 people die of 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.

The functions of the center include: to ensure the safety of substances and pigments added to food; to ensure the safety of food and ingredients developed through biotechnology; to be responsible for the management activities in the correct identification of food (such as ingredients, nutritional health statements) and cosmetics; to formulate corresponding policies and regulations to manage dietary supplements, infant food formulas and medical foods; and to ensure the safety of cosmetics To ensure the safety of food ingredients and products; to supervise and regulate the after-sale behavior of food industry; to carry out consumer education and behavior development; to cooperate with state and local governments; to coordinate international food standards and safety.


Introduction to testing


Food and Drug Administration (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 radiation products produced or imported in the United States. It is one of the earliest federal agencies whose main function is to protect consumers.


Test standard


1. FDA application process

1.1. enterprise registration

a) Application form for enterprise registration

b) FDA confirms and issues the serial number of the enterprise;

1.2. product registration

1.2.1 medical device products are classified into three categories according to the safety risk level:

a) List control of medical devices of category 1

b) Market access approval type 2 (i.e. 510 (k) approval)

c) Approval of PMA type 3 before entering the market

1.2.2 principal agent

Entrustment agreement for FDA registration and notification (signed by legal representative and stamped with company official seal)

1.2.3 provide information

a) Business license of enterprise legal person

b) Certificate of code of public institution legal person, registration certificate of legal person of association, etc. (copy with company official seal)

c) Qualification certificate or production license certificate within the validity period (copy with company official seal)

d) FDA registration application form (one for Chinese and English, with company seal)

e) FDA added additional documents (if any) required to be submitted.

f) Brief introduction to the enterprise (establishment time, economic performance, technical strength, main production varieties, performance and asset status).

1.3 payment

Free registration and listing;

510 (k) and PMA shall be paid according to the fee standards published on the FDA online.

1.4 registration

After the fee is charged, fda60 working days will be completed;

1.5 FDA website announced the registration status, 510 (k), PMA FDA sent approval access letter.



BORY Products

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