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.
What You Need to Know? 👇
What are “Cannot Rule Out” (CRO) results in FDA laboratory testing?
CRO results are preliminary indications that a sample may yield a final result presenting a public health hazard. These results indicate ongoing testing without confirmed final results, allowing responsible parties to make informed decisions about potential market hazards.
When can FDA share preliminary laboratory results with medical device manufacturers?
FDA may orally release CRO results for sterile medical devices after clearance and coordination with the respective Center, particularly when release serves public health interests and doesn’t interfere with investigations or enforcement proceedings.
What disclaimer must FDA provide when sharing preliminary analytical results?
FDA must state that CRO results are preliminary, shared for informational purposes only, don’t imply necessary action, and that responsible parties remain accountable for product safety. Final results will be provided when available.
How quickly can manufacturers obtain final FDA laboratory analytical results?
Upon request, FDA may release final ORA laboratory results without requiring a formal FOIA request. This allows responsible parties to take appropriate action or resume normal operations based on confirmed results.
What factors does FDA consider before releasing preliminary laboratory results?
FDA considers potential injury consequences, background danger information, consumer susceptibility, screening method accuracy, and whether release would interfere with investigations or enforcement proceedings before sharing CRO results.
Can FDA withhold laboratory analytical results from responsible parties?
Yes, FDA may withhold ORA laboratory results in limited cases, particularly when release is reasonably expected to interfere with ongoing investigations or enforcement proceedings, even after final results are available.
What You Need to Do 👇
Recommended Actions
- Establish internal procedures for evaluating when to share CRO results based on public health considerations
- Implement documentation system for all communications regarding laboratory results
- Create template for mandatory disclaimer statement when sharing CRO results
- Develop consultation workflow with relevant FDA Centers and Offices
- Train staff on proper procedures for sharing both preliminary and final results
- Set up process for evaluating requests for final results from responsible parties
- Create checklist for assessment of public health implications before sharing CRO results
- Establish coordination procedures for outbreak and emergency situations
- Implement tracking system for samples on hold pending final results
- 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
Related references and norms 📂
- 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 ID: ac7841649a53cf9598098323a74149b4