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Inspection and Field Testing Requirements for Radiation-Emitting Electronic Products

This guidance outlines inspection and field testing requirements for radiation-emitting electronic products, focusing on reporting and certification requirements that are common to all Electronic Product Radiation Control (EPRC) inspections and field tests.

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By ReguVirta
3 min read

What You Need to Know? 👇

What are the main reporting requirements for radiation-emitting electronic products under FDA regulations?

The FDA requires product reports (1002.1), supplemental reports (1002.11), annual reports (1002.13), and accidental radiation occurrence reports (1002.2). All violations are classified as Minor Class B infractions during inspections.

What certification requirements must manufacturers meet for radiation-emitting medical devices?

Manufacturers must provide certification labels (1010.2), maintain adequate testing programs, and include proper identification labels (1010.3) with complete manufacturer information including address and proper date formatting.

What happens if a manufacturer lacks a testing program for radiation-emitting products?

Inadequate or lack of testing program is classified as a Major Class A violation, the most serious category. However, if a program exists but lacks records, it’s downgraded to Minor Class B.

How should manufacturers properly label radiation-emitting electronic products for FDA compliance?

Labels must include proper identification (1010.3), avoid coded/abbreviated dates, include complete manufacturer address, and reference current FDA standards rather than outdated DHEW or BRH references.

What classification system does FDA use for radiation-emitting product inspection violations?

FDA uses three classes: Class A (Major violations), Class B (Minor violations), and Class C (Concern level). Missing testing programs are Class A, while most reporting failures are Class B.

Where can manufacturers submit comments about FDA radiation-emitting product guidance documents?

Comments can be submitted online or mailed to Dockets Management, FDA, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. All comments should reference docket number FDA-2020-D-0957.

What You Need to Do 👇

  1. Establish a robust documentation system for all required reports (product, supplemental, annual, and accidental radiation occurrence)
  2. Implement and maintain a comprehensive testing program with proper record-keeping
  3. Review and update all product labeling to ensure compliance with identification and certification requirements
  4. Create a checklist for label requirements including manufacturer address, date format, and proper identification
  5. Develop a system to track and submit reports according to required timelines
  6. Conduct regular audits of testing programs and documentation to ensure ongoing compliance
  7. Train relevant personnel on reporting requirements and testing procedures
  8. Establish a process for immediate reporting of accidental radiation occurrences
  9. Review and update any outdated references (DHEW or BRH) on existing documentation or labels

Key Considerations

Non-clinical testing

  • Testing program must be adequate and complete
  • Testing records must be maintained
  • Testing deficiencies must be addressed

Labelling

  • Certification label must be present
  • Identification label must be present
  • Date format must not be coded or abbreviated
  • Manufacturer’s complete address must be included
  • References to DHEW or BRH should be updated

Other considerations

  • Product reports must be submitted as required
  • Supplemental reports must be submitted as required
  • Annual reports must be submitted as required
  • Accidental radiation occurrence reports must be submitted as required
  • For non-consumer products, month and year can be included in serial number

Relevant Guidances 🔗

Original guidance

  • Inspection and Field Testing Requirements for Radiation-Emitting Electronic Products
  • HTML
  • Issue date: 2007-10-30
  • Last changed date: 2020-03-24
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Postmarket
  • ReguVirta ID: 9618fc61717e0dd22e287da78b9ea082
FDA guidance, Final
Medical Devices Radiation-Emitting Products Postmarket
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