1, referred to as FDA, is one of the executive agencies established by the US government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS).
As a scientific management organization, the duty of FDA is to ensure the safety of food, cosmetics, medicines, 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.
This institution is closely related to the life of every American citizen. Internationally, FDA is recognized as one of the largest food and drug administrations in the world. Many other countries seek and accept the help of FDA to promote and monitor the safety of their products.
Extended data:
Application process-enterprise registration: enterprise registration application form, FDA confirmation release, enterprise serial number.
Product registration:
Medical device products are divided into three categories according to the degree of safety risk:
1 and 1 List control of medical equipment
2, two kinds of market access recognition (that is, 5 10(K) recognition)
3.3 Approval of the entrustment agreement for registration and notification of Class PMA before listing 1. 2. 2 FDA (signed by the legal representative and stamped with the official seal of the company).
Business license of enterprise legal person:
1, enterprise legal person code certificate, enterprise legal person registration certificate, etc. (Copy stamped with the official seal of the company) c) Qualification certificate or production license certificate within the validity period (copy stamped with the official seal of the company) d) FDA registration application form (one in Chinese and one in English, stamped with the official seal of the company) e) Other documents newly required by the FDA (if any).
2. Brief introduction of the enterprise (establishment time, economic performance, technical strength, main production varieties, performance and assets). Paid registration and listing are free; 5 10(K) and PMA shall be paid according to the charging standard published by FDA online.
3. Complete registration within 60 working days after charging; The FDA website announced the registration status, and FDA's 5 10(K) and PMA sent another approval letter.
References:
Baidu encyclopedia -FDA certification