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.
What You Need to Know? 👇
What is the Abbreviated 510(k) Program and how does it differ from Traditional 510(k)?
The Abbreviated 510(k) Program is an optional approach that uses FDA guidance documents, special controls, and/or voluntary consensus standards to facilitate premarket review. It allows manufacturers to submit summary reports instead of full data, potentially making review more efficient than Traditional 510(k) submissions.
When can a manufacturer choose to submit an Abbreviated 510(k) instead of a Traditional 510(k)?
Manufacturers may submit an Abbreviated 510(k) when their submission relies on one or more of the following: FDA guidance documents, demonstration of compliance with special controls for the device type, and/or voluntary consensus standards recognized by FDA.
What happens if FDA determines an Abbreviated 510(k) submission is inappropriate for the program?
If FDA believes an Abbreviated 510(k) is not appropriate for review under the program, FDA will convert the submission to a Traditional 510(k) and notify the submitter. The review will then proceed under Traditional 510(k) requirements.
What is a summary report in an Abbreviated 510(k) and what should it contain?
A summary report describes how FDA guidance documents were used to demonstrate substantial equivalence and/or how the device complies with special controls. It should include device description, design requirements, risk management information, test methods, and any deviations from guidance recommendations.
Does the Abbreviated 510(k) Program change the statutory requirements for substantial equivalence?
No, the Abbreviated 510(k) Program does not alter any statutory or regulatory requirements related to the premarket notification process under sections 510 and 513 of the FD&C Act, and 21 CFR 807 subpart E. It’s simply an alternative approach.
What are the review timelines for Abbreviated 510(k) submissions compared to Traditional 510(k)s?
FDA intends to review Abbreviated 510(k) submissions within the same 90-day statutory deadline and MDUFA performance goals as Traditional 510(k)s. However, FDA believes the review may be more efficient due to the streamlined summary report format.
What You Need to Do 👇
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 ID: 5cf453398babbcd1183832f610b7e887