Instruction of FDA

Instruction of FDA

The United States Food and Drug Administration (FDA or USFDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying from household pets to human sperm donated for use in assisted reproduction.

The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. Stephen M. Hahn, MD is the current commissioner, as of December 2019.

The FDA has its headquarters in unincorporated White Oak, Maryland. The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.

Our ice packs are all pased FDA certification to meet the standard of FDA.

FDA certification process:

The first step: application acceptance

1. After receiving a qualified application, the certification dept. will issue a notice of acceptance to the applicant to notify the applicant to send or post relevant documents and materials.

2. At the same time, the certification dept. sends relevant charges and notices.

3. The applicant shall provide the information to the certification dept. as required.

4. After the applicant pays, fill in the payment voucher as required.

Step 2: Data review

1. In the data review stage, the product certification engineer needs to divide the application unit.

2. After the unit is divided, if sample testing is required, the product certification engineer sends a sample delivery notice and corresponding payment notice to the applicant, and at the same time, informs the applicant to send a sample receipt notice to the corresponding testing agency.

Step 3: Sample reception

1. The sample shall be delivered directly to the designated testing institution by the applicant.

2. After the applicant pays, fill in the payment voucher as required.

3. The testing agency shall check and accept the collected samples, fill in the sample acceptance report, and issue a sample rectification notice for unqualified samples, and fill in the sample acceptance report after rectification.

4. After the sample is checked and accepted, the testing agency shall fill in the sample testing schedule and submit it to the certification agency.

5. After receiving the progress of the sample testing, the certification body will issue a formal acceptance notice to the applicant after confirming that the applicant’s related fees have been paid, and the testing agency will issue a test task letter, and the sample testing will officially start.

Step 4: Sample testing

1. The work that the enterprise should do in the type test stage is: send test samples, required parts and technical data, understand the test progress, if there are unqualified items, make timely corrections in accordance with the sample test correction notice.

2. After the sample test is over, the testing agency will fill in the sample test result notification.

3. The testing agency will also send the test report and other data to the certification agency.