With some meat and poultry exceptions, most of food, drugs, biologic, cosmetics, medical devices, tobacco and electronic products that emit radiation, as defined in the FD&C and related Acts, are subject to FDA jurisdiction when they are being imported or offered for import into the United States.
Form FDA 2877 (outdated MS Word version is available here), Declaration for Radiation Standard, is required for radiation-emitting electronic products entering the United States.
21 CFR 1005 – 1050 addresses the performance standards for electronic products. If device is not listed as being subject to the performance standards for electronic products (ex. infra-red remote controls), then it does not need to be declared with FDA.
Examples of radiation emitting electronic products subject to the provisions of the FD&C Act and therefore regulated by FDA are listed in 21 CFR 1000.15.
Following are some of the links one might find useful:
- Action Levels for Poisonous or Deleterious Substances
- Center for Devices and Radiological Health
- Color Additives: Color Additives and Cosmetics
- Color Additives: Summary of Color Additives Listed for Use in the United States in Food, Drugs, Cosmetics, and Medical Devices
- Cosmetics
- Drug Registration and Listing
- Flags, HTSUS
- HACCP: Seafood
- Import Refusal Reports
- Manuals (Compliance Policy Guides)
- MDL: Device Listing Database
- MDL: Device Listing Guidance
- MDL: Premarket Notification
- MDL: Product Classification Database
- MDL: Registration and Device Listing Information
- Product Code Building
- Regulatory Procedures Manual
- Import Alerts
