The FDA’s regulatory agency for food, agricultural products and seafood is the Center for Food Safety and Nutrition (CFASAN), whose responsibility is to ensure that American food supply is safe, clean, fresh and clearly marked.

The food import supervised by the Center is 240 billion US dollars per year, of which 15 billion is imported food. The main monitoring focuses of the Center include:

1. Food freshness;
2. Food additives;
3. Other harmful ingredients of food biotoxin;
4. Safety analysis of marine products;
5. Food identification;
6. Follow-up and warning after food marketing

According to the anti-terrorism law passed by the United States Congress in 2003, food enterprises outside the United States must register with FDA before exporting to the United States, and notify FDA of the shipment when exporting

FDA’s management of medical devices is conducted through the Center for Devices and Radiological Health (CDRH), which supervises the production, packaging and dealers of medical devices to conduct business activities in compliance with the law.

The range of medical devices is very wide, ranging from medical gloves to cardiac pacemakers, which are under the supervision of FDA. According to the medical use and possible harm to human body, FDA classifies medical devices into categories I, II and III, and the higher the category, the more the supervision. If the product is a novel invention that has never existed in the market, FDA requires the manufacturer to carry out strict human body experiments and have convincing medical and statistical evidence to prove the effectiveness and safety of the product.

1、ApplicationForm

Application form: including company information, product information, etc

2、ProductFile/TechnologySpecification

Product documents/technical data: mainly including preparation of detailed instructions/sales manuals, installation manuals, maintenance manuals, etc; Product assembly drawing; And product technical information, whether there are laser protection measures and their working principle description.

3、Label

Labels: English labels conforming to the regulations, warning labels including warning signs, product labels, compliance certification labels (such as Compliesworth 21CFR1040.10&1040.11), and light outlet label, etc.

4、LaserInformation

Laser device information: laser generator type, medium, laser optical path diagram, laser parameters, laser device certificate/test record (if purchased from other manufacturers, the manufacturer’s information, laser device parameters/datasheet or instructions, and whether the laser device has FDA certification/FDA number are required).

5、CalibrationReportofPowerMeter

Annual metrological verification certificate and report of optical power meter.

6、QualityControlSystem

Quality control documents: mainly including internal quality control flow chart, inspection procedures, quality control specifications/such as design modification control; Production line sampling form, incoming material inspection form, finished product inspection form, internal inspection report, etc. (including samples of the form).

7、USAgent/Importer

US agent and US importer information: including contact person’s full name, telephone/fax/email, US detailed address/postal code, company name; And the U.S. Agent proxy authorization agreement.

1. Submit application forms, samples and relevant materials;
2. Test and issue report;
3. Submit to FDA for review;
4. Issue number and certificate after review.

With complete data and samples, 3-4 cycles of conventional products.