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.
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
- 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