Post

Requesting Nonbinding Feedback on Form FDA 483 Inspectional Observations

This guidance explains how device establishment owners can request nonbinding feedback from FDA regarding their proposed actions to address certain inspectional observations documented on Form FDA 483. It outlines the submission process, eligibility criteria, and FDA's evaluation and response procedures.

  1. Review Form FDA 483 observations to determine if they meet eligibility criteria (public health priority, systemic issues, or emerging safety concerns)
  2. Prepare request package within 15 business days including:
    • Clear identification as feedback request
    • Contact information and establishment details
    • Detailed justification for eligibility
    • Comprehensive corrective action plan with timeline
    • Supporting documentation
  3. Submit request to designated FDA contact provided during inspection
  4. If feedback received, evaluate FDA’s recommendations for:
    • Adequacy of proposed actions
    • Additional measures needed
    • Implementation planning
  5. Document implementation of corrective actions, whether following FDA feedback or alternative approach
  6. Maintain awareness that implementing FDA’s feedback does not guarantee compliance or prevent future regulatory action

Key Considerations

Safety

  • Observations must involve public health priority that could result in release of violative products causing death or serious injury
  • Observations must relate to emerging safety issues that could result in devices likely to cause death or serious injury
  • Systemic or major deficiencies must be addressed to prevent release of nonconforming devices that pose serious public health risks

Other considerations

  • Request must be submitted within 15 business days after Form FDA 483 issuance
  • Request must come from owner, operator, agent in charge or designated representative
  • Request must include clear identification as “Request for Nonbinding FDA Feedback After a Device Inspection”
  • Detailed justification explaining how observations meet eligibility criteria must be provided
  • Proposed corrective actions with timeline and supporting documentation must be included
  • FDA will respond within 45 calendar days if request meets eligibility criteria

Original guidance

  • Requesting Nonbinding Feedback on Form FDA 483 Inspectional Observations
  • HTML / PDF
  • Issue date: 2020-04-22
  • Last changed date: 2020-04-21
  • Status: FINAL
  • Official FDA topics: Medical Devices, Postmarket
  • ReguVirta summary file ID: eada28d5f124bb0780cf468b4d3f6126
This post is licensed under CC BY 4.0 by the author.