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AK Science Research Intemational Co. AK Science Asia Co.,LTD

FDA items

·Written by : administrator   ·Date of writing : 2022-06-13  

 

1. Food
A. General food (naturally processed-frozen-confectionery, etc.) *excluding tea
1F-0. Facility Registration - Mandatory ※ Agent in the US (contact information)
1F-1. Nutrition Facts: Labeling method - Mandatory
1F-2. Heavy metal inspection: 8~17 items Metal
1F-3. Residual safety inspection: about 20 tests
1F-4. Microbial inspection: Inspection items according to the characteristics of buyers and products
B. Low-acid food (sterilized products for long-term storage through heating, such as pouches, canned foods, bottles, etc.)
1F-10. FCE: Registered as a factory for manufacturing low-acid and acidified foods
1F-11. SID: Product Production Process: Process Registration

2. Cosmetics
A. Products eligible for voluntary cosmetic registration (not mandatory)
- Skin irritation test
- Eye irritation test
- Acute oral toxicity test
- Heavy metal test
B. Functional cosmetics (sun cream, fluoride toothpaste, dandruff removal shampoo, wrinkle care products)
- Registration of OTC (over the count) cosmetics as quasi-drugs

3. Medical device
Class 1 medical equipment: Class l Devices (low risk… products subject to general regulation)
Company registration (factory registration)
Product registration: Submit Medical Divice Listing
Class 2: Class II medical devices: Class II (moderate risk, special regulation)
Company registration (factory registration)
Product registration: Submit Medical Divices Listing
510K (pre-market report) submission document review fee (takes 3-6 months)
Class 3: Class III Medical Devices: Classlll Devices (high risk, premarket approval (PMA))
Premarket Approval (PMA) document review fee (takes 6 to 12 months)
Request for clinical trial data to prove efficacy (510K document + supplement)
Classification by medical device is in the US Code of Federal Regulations (CFR) Volume 21 (title).

4. Others
4-1. Chemical material CFR21 Part174~177. dissolution test cost
4-2. Paint... Stability and efficacy test inspection fee (depending on use)
4-3. animal feed... Stability test inspection fee (for livestock and pets)
*Clinical 123 costs for drug approval related matters, time omitted.