Overview of Laws and Regulations

• Overlap of FDA Enforcement Authorities for Radiation-Emitting Products (chart) (PDF)
• Summary of Electronic Product Radiation Control
• Radiation Control Law - FFDCA, Chapter V, Subchapter C
• Code of Federal Regulations (CFR), Title 21, Subchapter J ( Title 21 CFR § 1000 - 1050 ) Text
  • Title 21, Subchapter J is also available as the following pieces:
  • General Requirements for All Electronic Products which Emit Radiation ( Title 21 CFR § 1000 - 1005 ) Text
  • General Performance Standard ( Title 21 CFR § 1010 ) PDF
    This regulation covers: Certification to Standards; Identification; and Variances
  • Specific Performance Standards for Electronic Products which Emit Radiation (Title 21 CFR § 1020 - 1050 ) Text
• Relationship of Laws and Regulations (chart) PDF