Post

List of Device Types That Require Human Factors Data in Premarket Submissions (DRAFT)

This guidance identifies medical device types that require human factors data in premarket submissions (PMA, 510(k)) due to their potential for serious harm resulting from use errors. It provides clarity on FDA's expectations regarding human factors testing submissions.

This is a draft guidance. Not for implementation.

  1. Review if your device is on the priority list for human factors review
  2. If listed, prepare human factors test report following FDA guidance format
  3. If not submitting human factors data for a listed device, prepare detailed justification
  4. For non-listed devices, conduct risk analysis to determine if human factors data is needed
  5. Consider additional triggers that might require human factors data even for non-listed devices
  6. Ensure human factors testing is integrated into design control process
  7. Document all human factors related decisions and rationales
  8. Consider consulting with FDA if unclear about human factors data requirements

Key Considerations

Human Factors

  • Human factors data must be submitted for specific listed devices (e.g., ablation generators, anesthesia machines, artificial pancreas systems, etc.)
  • A human factors test report should follow the format described in “Applying Human Factors and Usability Engineering to Medical Devices”
  • If no human factors data is submitted, a detailed rationale must be provided explaining why it’s not necessary
  • For non-listed devices, human factors data is required if risk analysis shows potential serious harm from use errors

Other considerations

  • No specific norms or standards are referenced in this guidance

Original guidance

  • List of Device Types That Require Human Factors Data in Premarket Submissions
  • HTML / PDF
  • Issue date: 2016-02-03
  • Last changed date: 2019-05-14
  • Status: DRAFT
  • Official FDA topics: Medical Devices, Errors, Postmarket, and Problems, Premarket Approval (PMA), Labeling, Premarket, Investigational Device Exemption (IDE), Safety - Issues
  • ReguVirta summary file ID: afabde7181e52efc186834b9c9e57091
This post is licensed under CC BY 4.0 by the author.