Safety and Performance Based Pathway for 510k Substantial Equivalence Demonstration
This guidance introduces the Safety and Performance Based Pathway as an optional pathway for demonstrating substantial equivalence in 510(k) submissions. It applies to well-understood device types where submitters can demonstrate that a new device meets FDA-identified performance criteria to prove it is as safe and effective as a legally marketed device, instead of direct comparison testing.
What You Need to Know? 👇
What is the Safety and Performance Based Pathway for 510(k) submissions?
The Safety and Performance Based Pathway is an optional FDA program that allows medical device manufacturers to demonstrate substantial equivalence by meeting FDA-identified performance criteria rather than conducting direct comparison testing against predicate devices for certain well-understood device types.
Which devices are eligible for the Safety and Performance Based Pathway?
Devices eligible for this pathway must have the same intended use and technological characteristics that don’t raise different safety questions compared to predicate devices. FDA maintains a list of appropriate device types on their website with corresponding guidance documents.
What documentation is required for Safety and Performance Based Pathway submissions?
Required documentation varies based on performance criteria source: Declaration of Conformity for FDA-recognized standards, results summary plus Declaration of Conformity for FDA-established criteria with recognized testing methods, or complete test reports for alternative methodologies.
How does the Safety and Performance Based Pathway reduce regulatory burden?
This pathway can be less burdensome than traditional predicate comparison testing while maintaining robust safety standards. It may also make FDA reviews more efficient, potentially reducing review times while satisfying statutory requirements for substantial equivalence.
Can manufacturers still use traditional 510(k) pathways if their device qualifies for the Safety and Performance Based Pathway?
Yes, the traditional 510(k) pathways (Traditional, Special, and Abbreviated 510(k)s) remain available to all submitters. The Safety and Performance Based Pathway is an optional alternative approach for eligible devices.
How does FDA establish and maintain performance criteria for this pathway?
FDA develops performance criteria based on staff expertise, literature analysis, and existing device data to ensure criteria represent performance levels equivalent to legally marketed devices. The agency periodically reviews and updates criteria through guidance documents following Good Guidance Practices.
What You Need to Do 👇
Recommended Actions
- Verify device type is listed as eligible for Safety and Performance Based Pathway on FDA website
- Identify appropriate predicate device and confirm:
- Same intended use
- No new safety/effectiveness questions from technological characteristics
- Review FDA guidance for specific performance criteria and testing methods for the device type
- Prepare submission including:
- Required 510(k) elements per 21 CFR 807.87
- Declaration of Conformity and/or test results demonstrating performance criteria are met
- Appropriate documentation based on testing methodology used
- Consider seeking FDA feedback if unclear about eligibility or requirements
- Maintain awareness of any changes to device type eligibility or performance criteria
- Consider traditional 510(k) pathway as alternative if needed
Key Considerations
Non-clinical testing
- Performance criteria must be met using appropriate testing methods
- Testing methods can be either FDA-recommended or alternative methods
- Results must be documented through Declaration of Conformity, results summary, testing protocols, and/or complete test reports depending on the testing methodology used
Labelling
- Must provide labeling information as in traditional 510(k)
- No direct comparison testing against predicate device required
Biocompatibility
- Must provide biocompatibility information as in traditional 510(k)
- No direct comparison testing against predicate device required
Safety
- Device must have same intended use as predicate device
- Technological characteristics must not raise different safety and effectiveness questions
- Performance criteria must represent performance levels at least equivalent to legally marketed devices
Other considerations
- Device type must be identified by FDA as appropriate for this pathway
- Predicate device must still be identified
- FDA maintains list of eligible device types and associated performance criteria
- Third party review remains available for eligible devices
- Traditional 510(k) pathway remains available as alternative
Relevant Guidances 🔗
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- The Abbreviated 510k Program: Using Guidance Documents, Special Controls, and Standards for Substantial Equivalence Demonstration
- Special 510k Program for Device Modifications: Eligibility Criteria and Submission Requirements
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms 📂
- 21 CFR 807.87: Content requirements for premarket notifications
- 21 CFR 10.115: Good Guidance Practices