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Real-Time Review Process for Minor Changes to Approved Medical Devices through PMA Supplements

This guidance outlines the real-time review process for PMA supplements, specifically focusing on minor changes to approved medical devices. It provides information about the criteria, procedures for requesting and submitting real-time PMA supplements.

  1. Contact the Assistant Director in the appropriate Review Division to discuss eligibility for real-time review
  2. Submit email request for real-time review including:
    • Contact information
    • PMA document number
    • Target submission date
    • Proposed meeting dates
    • Reason for submission
    • Brief explanation of changes
    • Preferred meeting type
  3. Prepare submission package containing:
    • Detailed description of all modifications
    • Testing results
    • Comprehensive risk assessment
    • FDA’s response granting real-time review request
  4. Submit eCopy with paper cover letter at least 3 weeks before scheduled meeting
  5. Pay required user fee upon submission
  6. Prepare for interactive review process including potential meetings or other communications with FDA

Key Considerations

Non-clinical testing

  • Changes must be validated according to accepted scientific principles and test methods
  • Pre-clinical or animal testing should adequately support the changes
  • No new clinical data should be required

Software

  • Minor software changes are eligible for real-time review

Labelling

  • Changes to instructions for use, warnings, or precautions that do not affect indications or contraindications
  • Minor labeling changes are eligible

Safety

  • Must include detailed risk assessment of all potential hazards
  • Must consider both incremental modification and cumulative effects of preceding modifications
  • Must identify steps taken to minimize additional risks

Other considerations

  • No specific norms or ISO standards mentioned in the guidance

Original guidance

  • Real-Time Review Process for Minor Changes to Approved Medical Devices through PMA Supplements
  • HTML / PDF
  • Issue date: 2019-12-16
  • Last changed date: 2020-03-24
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket Approval (PMA), Device & Drug Safety, Premarket, Biologics, Administrative / Procedural
  • ReguVirta summary file ID: fc28f9b470642fabb74647b2b97a76f9
This post is licensed under CC BY 4.0 by the author.