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Policy for Monkeypox Testing During the Public Health Emergency

This guidance outlines FDA's policies and recommendations for expanding testing availability for monkeypox or other non-variola orthopoxviruses during the public health emergency. It applies to certain laboratories certified under CLIA for high-complexity testing and commercial manufacturers developing monkeypox tests.

  1. Determine if test falls under enforcement discretion policy scope
  2. Validate test according to FDA recommendations
  3. Submit notification to FDA within required timeframe
  4. Implement appropriate result reporting and labeling
  5. Monitor FDA communications for policy updates
  6. Maintain compliance with MDR requirements
  7. Consider submitting EUA request if test is outside enforcement discretion
  8. Collaborate with original test developer for modifications
  9. Post validation data on website for modified tests
  10. Notify FDA of any significant problems or concerns

Key Considerations

Clinical testing

  • Tests must be appropriately validated before use
  • Clinical validation initially recommended with contrived specimens
  • Clinical samples may be required when more widely available

Non-clinical testing

  • Limit of Detection (LoD) evaluation required
  • Performance should be consistent with FDA-cleared CDC test for tests using identical primers/probes

Labelling

  • Test reports must disclose if test has not been FDA reviewed
  • For serology tests, specific disclaimers required about limitations
  • No false/misleading statements about FDA review/authorization

Other considerations

  • 21 CFR Part 803: Medical Device Reporting
  • 21 CFR 866.3315: Non-variola Orthopoxvirus serological reagents

Original guidance

  • Policy for Monkeypox Testing During the Public Health Emergency
  • HTML / PDF
  • Issue date: 2022-09-07
  • Last changed date: 2022-09-13
  • Status: FINAL
  • Official FDA topics: Medical Devices
  • ReguVirta summary file ID: 550852504d14feac641ac1c3b773b8ce
This post is licensed under CC BY 4.0 by the author.