Records and Reporting (Radiation-Emitting Products)

• Reports of problems and hazards
• FDA eSubmitter Program
• Required reports
• Variance requests
• Records to be maintained
• Addresses

Reports of problems and hazards:

• Radiological Health Definitions (21 CFR 1000.3)
• Accidental Radiation Occurrences and Radiation Incidents (21 CFR 1002.20)
• Accidental Radiation Occurrence Report

• Reporting a Radiation Safety Defect in an Electronic Product or a Failure to Comply with a Federal Performance Standard (21 CFR 1003)

• Exemptions from User Notifications and Product Corrections (21 CFR 1003.30)
• Corrective Action Plans for Noncompliant or Defective Products (Repair, Repurchase, or Replace) (21 CFR 1004)

FDA eSubmitter Program:

The FDA eSubmitter program allows you to submit many Product Safety Reports and Annual Reports electronically. This free software is available for voluntary use by manufacturers in the Radiological Health industries. For more information about see FDA eSubmitter.

Required reports:

• Records and Reports (21 CFR 1002)
• Reporting and Recordkeeping Requirements by Product (21 CFR 1002.1, Table 1).
• Reports Required Prior to Introduction of an Electronic Product which Emits Radiation into United States' Interstate Commerce
  • 21 CFR 1002.10 Product Reports
  • 21 CFR 1002.11 Supplemental Reports
  • 21 CFR 1002.12 Abbreviated Reports
• Annual Reports (21 CFR 1002.13)
  To find actual downloadable PDF forms for the reports identified above, you need to look under your specific product area. See the A-Z List of Regulated Products and Procedures. Each page has a section of information related to Industry Guidance.
• Exemptions from Reporting
  • 21 CFR 1002.50, Special exemptions
  • 21 CFR 1002.51, Exemptions for manufacturers of products intended for the U.S. Government

Variance requests:

• Certification to Standards, Identification, and Variances (21 CFR 1010.4)

Records to be maintained:

• Recordkeeping on Radiation Testing, Quality Control, and Complaints (21 CFR 1002.30)
• Preservation and inspection of records ( 21 CFR 1002.31)
• Recordkeeping on Product Distribution (21 CFR 1002.40)

Addresses:

• Addresses for Electronic Product Radiation Control Reports and Recordkeeping