FDA > CDRH > Radiological Health Program > Regulated Industry > Laws, Regulations and Standards > Overview of Laws and Regulations

Overview of Laws and Regulations

• Overlap of FDA Enforcement Authorities for Radiation-Emitting Products (chart) PDF
• Summary of Electronic Product Radiation Control Text
• Radiation Control Law - FFDCA, Chapter V, Subchapter C Text
• 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

Updated January 7, 2009