The U.S. FDA (Food    Drug  Admistraton for short FDA) is the U.S. Food Drug Administration, which is subordinate to the U.S. Department of Health, Education Welfare. Some people say that it is equivalent to China’s National Drug Administration, but it’s actually inaccurate. . To be precise, the US FDA is equivalent to my country's Ministry of Health (responsible for the approval of health food) the National Medical Products Administration (responsible for the approval of drugs) two industry regulatory agencies. It is responsible for the management of drugs, food, biological products, cosmetics, veterinary drugs, Yiliao devices, diagnostic supplies in the United States, is committed to protecting, promoting improving the health of the people, ensuring that the food, drugs, cosmetics Yiliao devices sold in the US market are The safety effectiveness of the human body.
　

FDA has six bureaus, namely, the Drug Administration, Food Administration, Veterinary Drug Administration, Radiological Health Administration, Biological Products Administration, Yiliao Device Diagnostics Bureau, National Toxicology Research Center, regional work management agencies (some publications also Called 6 centers), one center one regional management agency.

Scope of FDA:

Yliao products for X-ray diagnostics (general purpose, fluorescent X-ray, CT, etc.)

Surgery other laser equipment equipment with laser unit

Special purpose laser products (including display, observation medical)

Ultraviolet treatment equipment (Ultraviolet lamp products for Yliao)

Other medical ultrasound equipment other than physical therapy diagnosis

Microwave diathermy therapy microwave blood heater

Ultrasound physical therapy equipment

Electronic products with ionizing radiation:
　

TV video monitor with CRT display mode

Electronic products with non-ionizing radiation:

Microwave oven

Sun lamps sun lamp products (sun beds)

Cellular mobile phone

Laser products: including laser pointers, laser demonstrations, laser displays, products containing laser units (CD players, DVDs, CD-ROMs, laser printers, etc.)  safety protection rescue products

X-ray equipment with protective housing (such as X-ray inspection system, X-ray imaging system, X-ray security inspection system, X-ray baggage inspection system)

Industrial scientific products:

Laser tools laser instruments

X-ray equipment for non-Yliao diagnosis

RF microwave products (not microwave ovens)

Non-diagnostic therapeutic ultrasound products

FDA implements two types of management for food, drugs equipment, namely: Approved (Approved) Notification(notification)

YIiao product management classification:

Class I——These products pose little risk to users, are usually simpler in design than Class II Class III, such as enemas.  47% of Yiliao products belong to this level, 95% of which do not require regulatory management.

Level II——Most Yiliao products belong to Level II, 43% of products belong to Level II, such as electric wheelchairs maternity products.

Level III——Products of this level are usually used to maintain or support human life, may cause potential harm or harm to people during use. For example: implantable cardiac pacemakers, breast-enhancing fillers, etc. 10% of Yiliao products belong to Class III.

For Class I products, 95% of them belong to Yiliao devices that are exempt from management, the products do not require notification or clearance procedures before being put on the market. However, manufacturers are required to register with the FDA list their main products. Such managed products include artificial stethoscopes, mercury thermometers, toilets, etc.

Introduction to the FDA certification of electronic products that emit radiation (non-nuclear energy):

Most importers know that the FDA is the competent authority for food, medicine, cosmetics, Yiliao equipment in the United States, but sometimes many people neglect radiation  emitting products (radiation  emitting  products) are also regulated by the agency One.

The legal source of FDA regulations f that emits radiation electronic products is Article 531-542 of Title 5 of the Federal Food, Drug Cosmetic Act (FEDERAL  FOOD,  DRUG,  AND  COSMETIC  ACT , Referred to as FD&C).

The so-called electronic products that emit radiation include TV antennas screens, microwave ovens, diagnostic X-ray equipment, X-ray or laser-related products (such as optical drives laser pointers).

Most electronic products that emit radiation are not recognized as Yiliao devices. However, if the manufacturer or distributor claims that the product has the function of Yiliao, the product must comply with the FDA's regulations on Yiliao devices. The main reason for the legislation of Congress to regulate electronic products that emit radiation is to prevent consumers from using such products to cause health effects.

Take laser-related products as an example. my country’s main export products, optical drives, must comply with FDA regulations. In addition, products containing optical drives are also included in the specifications, such as notebook computers. As far as optical drives are concerned, the FDA divides them into four categories based on the amount of radiation. The lasers contained in optical drives used by consumers generally belong to the first category (class  1), which is less dangerous. Before the first type of optical drive is sold in the United States, the industry must comply with the following FDA regulations:

1. Self-conity declaration ;

2, product registration;

3. Test stards;

4. Product reports (Product  Reports);

5. Annual reports (Annual  Reports);

The annual report should be mailed to the FDA on September 1st each year. If it is not d regularly, the product will be detained by the customs when it clears the customs. If the manufacturer negligently fails to mail the report in time causes the product to be detained, the U.S. Customs can accept the manufacturer to post the relevant materials clear the customs.

6. Test record;

7. Relevant records;

8. Regulations on warning signs;

FDA certification process

1. Preparation stage

Copy of corporate legal person license;

Production (sanitary) license, copy of certificate;

Company profile (established time, technical strength, main products perance, asset status).

2. Technical preliminary review application acceptance

Submit the English translation of DMF (Drug Master File) SOP (Stard Operating Procedure) to the agent;

According to the opinions of the agents, the above-mentioned documents shall be revised.

3. DMF data review

FDA carefully audits inspects the factory to check whether the DMF document is true;

If the FDA does not find a major error believes that it meets the requirements, it will propose a pre-approval inspection plan.

4. FDA inspection

The FDA inspector inspects the factory, asks questions, the factory must answer one by one;

If there is any doubt, the official will give the "483" (recommendation for rectification), if the problem is serious, the "483" will not be given.

5. FDA issues “approval letter”

The questions raised by the prosecutor on the “483” must be answered carefully. If there are any problems, they must be corrected certified immediately;

Questions that the prosecutor did not clarify, need to explain prove