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

 

Subchapter C: Electronic Product Control

• SEC. 531. [21 USC §360hh] Definitions
• SEC. 532. [21 USC §360ii] Electronic Product Radiation Control Program
• SEC. 533. [21 USC §360jj] Studies by the Secretary
• SEC. 534. [21 USC §360kk] Performance Standards for Electronic Products
• SEC. 535. [21 USC §360ll] Notification of Defects in, and Repair or Replacement of, Electronic Products
• SEC. 536. [21 USC §360mm] Imports
• SEC. 537. [21 USC §360nn] Inspection and Reports
• SEC. 538. [21 USC §360oo] Prohibited Acts
• SEC. 539. [21 USC §360pp] Enforcement
• SEC. 541. [21 USC §360rr] Federal-State Cooperation
• SEC. 542. [21 USC §360ss] Effect on State Standards

ResourcesForYou

• Exemptions From Electronic Product Regulations