The Abbreviated 510k Program: Using Guidance Documents, Special Controls, and Standards for Substantial Equivalence Demonstration
The guidance outlines an optional approach for demonstrating substantial equivalence in premarket notifications (510(k)s) through the Abbreviated 510(k) Program. This program leverages guidance documents, special controls, and voluntary consensus standards to facilitate FDA's premarket review while maintaining the statutory criteria for substantial equivalence.
Recommended Actions
- Determine if your device is eligible for the Abbreviated 510(k) pathway based on applicable guidance documents, special controls, or consensus standards
- Prepare comprehensive summary reports that describe how guidance documents and special controls were used
- Include declarations of conformity for any voluntary consensus standards used
- Ensure all required elements are included (coversheet, device description, intended use, labeling, Form 3881)
- Document any alternative approaches with detailed justification
- Organize submission according to FDA’s format guidance for Abbreviated 510(k)s
- Include risk management documentation and test results in summary reports
- Address any aspects of the device not covered by guidance documents, special controls, or standards with additional data/information
Key Considerations
Non-clinical testing
- Summary reports must describe test methods used to address performance characteristics
- Testing information should address issues not covered by guidance documents, special controls, or voluntary consensus standards
Labelling
- Must include proposed labeling for the device
- Must include Indications for Use form (FDA Form 3881)
Safety
- Must demonstrate compliance with special controls when applicable
- Risk management information must be included in summary reports
Other considerations
- Must clearly identify submission as “Abbreviated 510(k)” on coversheet
- Must include device description and intended use
- Summary reports must describe how guidance documents were used
- When using voluntary consensus standards, a declaration of conformity is required
- Alternative approaches must be justified with sufficient detail
- Must include device design requirements in summary reports
Relevant Guidances
- 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
- Deciding When to Submit a New 510k for Changes to an Existing Medical Device
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
Related references and norms
- 21 CFR 807.87: Content requirements for premarket notification submissions
- 21 CFR 807 Subpart E: Premarket notification procedures
Original guidance
- The Abbreviated 510k Program: Using Guidance Documents, Special Controls, and Standards for Substantial Equivalence Demonstration
- HTML / PDF
- Issue date: 2019-09-13
- Last changed date: 2019-09-13
- Status: FINAL
- Official FDA topics: Medical Devices, 510(k), Premarket, Biologics
- ReguVirta summary file ID: 5cf453398babbcd1183832f610b7e887
This post is licensed under CC BY 4.0 by the author.