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Modular Submissions for Premarket Approval Applications and Humanitarian Device Exemptions

This guidance outlines procedures for submitting and reviewing modular Premarket Approval Applications (PMAs) and Humanitarian Device Exemptions (HDEs). The modular review approach allows applicants to submit non-clinical data and manufacturing information for review while still collecting clinical data using the final device design. The scope is limited to original PMAs and HDEs, as supplements would rarely be appropriate for modular review.

  1. Contact appropriate FDA review division to discuss intent to submit modular PMA/HDE
  2. Prepare and submit shell proposal including:
    • Content description for each module
    • Timeline for module submissions
    • Device description and principles of operation
  3. Wait for FDA acceptance of shell before submitting modules
  4. Submit modules according to agreed timeline with:
    • Cover letter referencing shell number
    • Table of contents
    • Executive summary
    • Complete test data and results
    • Relevant references
  5. Address any deficiencies identified during module reviews
  6. Submit final module including:
    • Clinical data
    • Proposed labeling
    • SSED/SSPB
    • Responses to any outstanding deficiencies
  7. Monitor and maintain communication with FDA review team throughout process
  8. Be prepared to submit amendments if device changes impact previously reviewed modules

Key Considerations

Clinical testing

  • Clinical data should typically be submitted in the final module
  • Clinical trial period and product development timeline should be carefully considered when planning module submissions
  • BIMO information can be submitted as separate module or with clinical module

Non-clinical testing

  • Complete all testing needed to support a specific module before submission
  • Non-clinical data can be grouped by disciplines (e.g., biocompatibility, engineering bench testing)
  • Results and analysis must be included for review

Software

  • Software validation and verification information should be included in appropriate module
  • Can be grouped with engineering/bench testing module

Labelling

  • Proposed labeling including physician instructions, patient instructions, operation manuals to be included in final module
  • Post-marketing plan should be included if appropriate

Biocompatibility

  • Biocompatibility/toxicity testing can be grouped in dedicated module
  • Complete testing results must be provided

Safety

  • Summary of Safety and Effectiveness Data (SSED) for PMAs or Summary of Safety and Probable Benefit (SSPB) for HDEs required in final module
  • Safety information should be included across relevant modules

Other considerations


Original guidance

  • Modular Submissions for Premarket Approval Applications and Humanitarian Device Exemptions
  • HTML / PDF
  • Issue date: 2025-01-13
  • Last changed date: 2025-01-13
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 9d2d6828eec1089e5cdd8074645b1e7c
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