Special 510k Program for Device Modifications: Eligibility Criteria and Submission Requirements
This guidance describes the Special 510(k) Program, which provides an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and design control procedures produce reliable results that can form the basis for substantial equivalence (SE). The guidance clarifies the types of technological changes appropriate for review as Special 510(k)s, including certain design and labeling changes.
Recommended Actions
- Review design changes to determine if a new 510(k) is required using risk-based assessment
- Evaluate if changes meet Special 510(k) criteria:
- Changes to manufacturer’s own device only
- Performance data can be summarized
- Well-established test methods available
- Maximum 3 scientific disciplines involved
- Prepare submission including:
- Clear identification as “Special 510(k): Device Modification”
- Description of changes and comparison to cleared device
- Risk analysis and design control activities summary
- Verification/validation results in summary format
- Declaration of conformity to standards if applicable
- Consider pre-submission consultation if uncertain about eligibility
- Be prepared for conversion to Traditional 510(k) if FDA determines Special 510(k) is not appropriate
- Maintain complete design control records for FDA inspection
- Follow 30-day review timeline expectations
- Address any FDA questions promptly during review to maintain expedited timeline
Key Considerations
Clinical testing
- Clinical studies or animal data to support SE are not typically appropriate for Special 510(k) Program
- Changes requiring clinical validation should be submitted as Traditional 510(k)s
Non-clinical testing
- Performance data must be able to be reviewed in summary or risk analysis format
- Well-established methods must be available to evaluate the changes
- Complete test reports should not be submitted
- Test methods and acceptance criteria should be standardized or previously accepted by FDA
Software
- Software changes may be appropriate if verification and validation approaches were previously identified in Traditional 510(k)s
- Results must be able to be summarized without requiring review of detailed test data
Labelling
- Certain labeling changes including indications for use may be appropriate
- Changes must be supported by verification/validation that can be summarized
- Complete clinical data should not be required to support labeling changes
Biocompatibility
- Changes requiring analytical chemistry testing using ISO 10993-18 and/or toxicological risk assessment using ISO 10993-17 are not appropriate
- Basic biocompatibility testing with standard methods may be acceptable if results can be summarized
Safety
- Changes must not compromise safety and effectiveness
- Risk analysis must demonstrate acceptable residual risks
- Design controls must be followed per 21 CFR 820.30
Other considerations
- Limited to manufacturer’s own legally marketed device
- Maximum 3 scientific disciplines involved in review
- 30-day review timeline
- Not appropriate for reprocessed single-use devices requiring validation data
- Not appropriate for devices manufacturing biological products at point of care
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Deciding When to Submit a New 510k for Changes to an Existing Medical Device
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Design Controls for Medical Device Manufacturers
Related references and norms
- ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances
- ISO 14971: Medical devices - Application of risk management to medical devices
- ISO 11137-1: Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control
- ASTM F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Original guidance
- Special 510k Program for Device Modifications: Eligibility Criteria and Submission Requirements
- HTML / PDF
- Issue date: 2019-09-13
- Last changed date: 2019-09-12
- Status: FINAL
- Official FDA topics: Medical Devices, 510(k), Premarket, Biologics, Administrative / Procedural
- ReguVirta summary file ID: aa6fd0be9093978bd7b635bba8b82f61
This post is licensed under CC BY 4.0 by the author.