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Release of Laboratory Test Results to Responsible Parties Without Freedom of Information Act Requests

This guidance outlines FDA's policy for releasing ORA laboratory analytical results (both final and preliminary) to responsible parties without requiring a FOIA request. It applies to samples collected during FDA regulatory activities and analyzed in ORA laboratories.

  1. Establish internal procedures for evaluating when to share CRO results based on public health considerations
  2. Implement documentation system for all communications regarding laboratory results
  3. Create template for mandatory disclaimer statement when sharing CRO results
  4. Develop consultation workflow with relevant FDA Centers and Offices
  5. Train staff on proper procedures for sharing both preliminary and final results
  6. Set up process for evaluating requests for final results from responsible parties
  7. Create checklist for assessment of public health implications before sharing CRO results
  8. Establish coordination procedures for outbreak and emergency situations
  9. Implement tracking system for samples on hold pending final results
  10. Develop protocol for documentation of responsible party’s response to shared results

Key Considerations

Non-clinical testing

  • Final laboratory results should generally not be released until testing is completed and report is accepted
  • Preliminary “Cannot Rule Out” (CRO) results may be shared orally in specific circumstances
  • Testing accuracy of screening method should be considered before sharing CRO results

Safety

  • Assessment of potential public health consequences before releasing CRO results
  • Consideration of consumer susceptibility
  • Special attention to sterility concerns for injectable, inhalation, topical or ophthalmic products
  • Evaluation of potential hazards and public health threats

Other considerations

  • Mandatory disclaimer statement when sharing CRO results
  • Consultation with relevant FDA Centers and Offices before sharing CRO results
  • Documentation of all communications with responsible parties
  • Results may be withheld if release could interfere with investigation or enforcement
  • Special coordination required for outbreak situations and emergencies
  • 21 C.F.R. §§ 20.20(a), 20.105: Regulations on public information
  • 21 C.F.R. Part 20, Subpart D: Confidentiality and disclosure
  • 21 C.F.R. Part 20, Subpart E: Records sharing with other entities

Original guidance

  • Release of Laboratory Test Results to Responsible Parties Without Freedom of Information Act Requests
  • HTML / PDF
  • Issue date: 2019-03-01
  • Last changed date: 2024-10-01
  • Status: FINAL
  • Official FDA topics: Radiation-Emitting Products, Tobacco, Medical Devices, Food & Beverages, Dietary Supplements, Investigation & Enforcement, Drugs, Animal & Veterinary, Biologics, Cosmetics, Administrative / Procedural
  • ReguVirta summary file ID: ac7841649a53cf9598098323a74149b4
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