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Best Practices for Selecting Predicate Devices in 510k Submissions (DRAFT)

This guidance provides recommendations for selecting predicate devices in 510(k) submissions. It aims to improve the predictability, consistency, and transparency of the 510(k) premarket review process by establishing best practices for predicate device selection. The guidance is meant to be used alongside the 510(k) Program Guidance without changing existing statutory and regulatory standards for substantial equivalence evaluation.

This is a draft guidance. Not for implementation.

  1. Search FDA databases to identify potential predicate devices with same intended use
  2. Review predicate device safety and performance by:
    • Checking MAUDE, MDR, and MedSun databases for adverse events
    • Reviewing Medical Device Safety website for emerging signals
    • Searching Medical Device Recalls Database
    • Evaluating test methods used for clearance
  3. Document predicate selection process including:
    • Analysis of well-established test methods used
    • Safety and performance history review
    • Assessment of any safety issues or recalls
    • Rationale for final predicate selection
  4. Include predicate selection narrative in 510(k) Summary explaining:
    • How best practices were applied
    • Any known issues with selected predicate
    • Mitigations implemented in subject device
  5. If no predicates meeting best practices are available:
    • Document why in 510(k) submission
    • Describe additional testing/mitigations implemented
    • Include explanation in 510(k) Summary

Key Considerations

Non-clinical testing

  • Select predicate devices cleared using well-established methods from:
    • FDA-recognized voluntary consensus standards
    • FDA guidance documents
    • Qualified medical device development tools (MDDT)
    • Widely accepted methods published in public domain/scientific literature
  • Consider if test methods used for predicate device remain appropriate for subject device evaluation

Human Factors

  • Consider any unmitigated use-related safety issues associated with predicate devices
  • Review safety communications and emerging signals related to use-related issues

Labeling

  • Review predicate device labeling for any safety-related updates or modifications
  • Consider if labeling adequately addresses known safety concerns

Safety

  • Select predicates that meet or exceed expected safety performance
  • Avoid predicates with:
    • Unmitigated design-related safety issues
    • Design-related recalls
    • High frequency of adverse events
  • Review safety databases (MAUDE, MDR, MedSun) for reported issues
  • Consider emerging safety signals and communications

Other considerations

  • ISO 13485: Medical devices – Quality management systems for regulatory purposes

Original guidance

  • Best Practices for Selecting Predicate Devices in 510k Submissions
  • HTML / PDF
  • Issue date: 2023-09-07
  • Last changed date: 2023-09-06
  • Status: DRAFT
  • Official FDA topics: Medical Devices, 510(k), Premarket, Biologics
  • ReguVirta summary file ID: 1822ad25fa2e80064868314d22863b7c
This post is licensed under CC BY 4.0 by the author.