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Electronic Products Radiation Control - Reports and Recorkeeping

• Accidental Radiation Occurrences and Radiation Incidents (Title 21 CFR § 1002.20)
• Address for Submission of Accidental Radiation Occurrence Reports
• Reporting a Radiation Safety Defect in an Electronic Product or a Failure to Comply with a Federal Performance Standard (Title 21 CFR § 1003)
• Address for Submission of Defect/Noncompliance Notifications
• Exemptions from User Notifications and Product Corrections (Title 21 CFR § 1003.30)
• Corrective Action Plans for Noncompliant or Defective Products (Repair, Repurchase, or Replace) (Title 21 CFR § 1004)

Required reports:

• Reporting and Recordkeeping Requirements by Product (Title 21 CFR § 1002.1, Table 1) (Note a Printer Friendly Version of this document is available from the GPO website)
• Reports Required Prior to Introduction of an Electronic Product which Emits Radiation into United States' Interstate Commerce (Title 21 CFR § 1002.10, § 1002.11, and § 1002.12)
• Title 21 CFR § 1002.10 Product Reports
• Title 21 CFR § 1002.11 Supplemental Reports
• Title 21 CFR § 1002.12 Abbreviated Reports
• Annual Reports (Title 21 CFR § 1002.13)
• Exemptions from Reporting (Title 21 CFR § 1002.50 and § 1002.51)
• Title 21 CFR § 1002.50, Special exemptions
• Title 21 CFR § 1002.51, Exemptions for manufacturers of products intended for the U.S. Government
• Address for Submission of Required Reports

See Title 21 CFR § 1002.7 Submission of data and reports for complete information.

• Reporting Guides for specific products, organized by product category

Variance Requests:

• Certification to Standards, Identification, and Variances (Title 21 CFR § 1010.4)
• Address for Submission of Variance Requests

Records to be maintained:

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

Note: For a complete copy of the Federal Food, Drug, and Cosmetic Act, Chapter V, Subchapter C - Electronic Product Radiation Control and the regulations promulgated under this section of the law go to the Overview of Electronic Product Radiation Control Laws and Regulations page.

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