Deciding When to Submit a New 510k for Changes to an Existing Medical Device

Recommended Actions

1. Document all device changes in quality system
2. For each change:
   • Determine if change is intended to significantly affect safety/effectiveness
   • Evaluate unintended consequences
   • Conduct risk assessment
   • Review applicable flowcharts and decision points
   • Consider cumulative effect with other changes
   • Document rationale for decisions
3. Submit new 510(k) if:
   • Change intended to significantly affect safety/effectiveness
   • Change creates new risks or significantly modifies existing risks
   • Clinical data needed for validation
   • Change affects indications for use
   • Change affects contraindications
   • Multiple changes cumulatively affect safety/effectiveness
4. Maintain documentation of change assessments including:
   • Description of changes
   • Rationale for changes
   • Risk analysis
   • Testing results
   • Decision documentation
5. Re-evaluate decisions if:
   • Initial assumptions not met
   • Unexpected test results
   • New information becomes available

Key Considerations

Clinical testing

• Clinical data is necessary when bench testing/simulations are insufficient to assess impact of change on safety/effectiveness
• Clinical data needed for design validation requires new 510(k)

Non-clinical testing

• Verification and validation required for all design changes
• Unexpected results from V&V may require re-evaluation of need for new 510(k)
• New test methods/acceptance criteria driven by design change likely requires new 510(k)

Human Factors

• Changes affecting user workflow require evaluation
• Changes to user interface that affect safety/effectiveness require new 510(k)
• Changes for user comfort may not require new 510(k) unless affecting function

Labelling

• Changes to indications for use statement usually require new 510(k)
• New contraindications require new 510(k)
• Minor clarifications may not require new 510(k)
• Changes affecting directions for use require evaluation

Cybersecurity

• Changes from wired to wireless communication likely require new 510(k)
• Changes to wireless protocols require evaluation

Biocompatibility

• New materials contacting body require biocompatibility evaluation
• Changes affecting sterilization may affect biocompatibility
• Processing changes may affect biocompatibility

Safety

• Changes intended to significantly affect safety require new 510(k)
• New risks or significantly modified existing risks require new 510(k)
• Risk assessment required for all changes

Other considerations

• Multiple simultaneous changes must be evaluated individually and in aggregate
• Documentation required for all changes
• Cumulative effect of changes must be considered
• Manufacturing changes must be evaluated for impact on device characteristics

  Relevant Guidances

• Deciding When to Submit a New 510k for Software Changes to Medical Devices
• Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
• Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
• MDUFA Performance Goals and Processing of 510k Submissions
• User Fees and Refunds for 510k Submissions

Related references and norms

• ISO 14971: Medical devices – Application of risk management to medical devices

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Original guidance

• Deciding When to Submit a New 510k for Changes to an Existing Medical Device
• HTML / PDF
• Issue date: 2017-10-25
• Last changed date: 2020-03-02
• Status: FINAL
• Official FDA topics: Medical Devices, Laboratory Tests, 510(k), Labeling, Premarket, IVDs (In Vitro Diagnostic Devices), Biologics
• ReguVirta summary file ID: e26cab5277166916f89889fa21f103db