Deciding When to Submit a New 510k for Changes to an Existing Medical Device
This guidance helps manufacturers of medical devices subject to premarket notification requirements determine when a change to a 510(k)-cleared device (or group of devices) requires submission of a new 510(k). It applies to changes made to: - 510(k)-cleared devices - Preamendments devices - Devices granted marketing authorization via De Novo classification process The guidance does not apply to: - Changes to 510(k)-exempt devices - Changes to devices requiring premarket approval (PMA) - Software changes (covered in separate guidance) - Combination products - Remanufactured/reprocessed single use devices without 510(k)
What You Need to Know? 👇
When is a new 510(k) required for device labeling changes?
A new 510(k) is typically required when labeling changes affect the indications for use, add/delete contraindications, change from single-use to reusable, or shift from prescription to OTC use.
What constitutes a significant change in device materials requiring 510(k) submission?
Material changes requiring new 510(k)s include new biocompatibility concerns for patient-contacting materials, unless the same material was previously used in similar legally marketed devices with equivalent contact conditions.
How should manufacturers assess technology changes using risk-based evaluation?
Conduct risk assessment identifying new or significantly modified existing risks. Changes in control mechanisms, operating principles, or energy types typically require 510(k) submission due to significant safety/effectiveness impacts.
What documentation is required when determining no new 510(k) is needed?
Document the decision-making process, change description, risk assessment, comparison to original device, applicable guidance elements, verification/validation results, and robust justification supporting the no-510(k) conclusion.
When do IVD modifications require new 510(k) submissions?
IVD changes requiring 510(k)s include those altering operating principles, identified in device-specific guidance, or when risk assessment shows new/modified risks affecting analytical/clinical performance around decision points.
What role does verification and validation play in 510(k) decision-making?
If initial risk assessment suggests no 510(k) needed, successful routine verification/validation confirms this decision. Unexpected results during testing require re-evaluation and likely 510(k) submission.
What You Need to Do 👇
Recommended Actions
- Document all device changes in quality system
- 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
- 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
- Maintain documentation of change assessments including:
- Description of changes
- Rationale for changes
- Risk analysis
- Testing results
- Decision documentation
- 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
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 ID: e26cab5277166916f89889fa21f103db