There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
When choosing to submit an abbreviated 510K the manufacturers must depend on the following for a successful submission:
- FDA Guidance Documents
- Voluntary Consensus Standards
- Demonstration of compliance with special controls for the device type1
The manufacturers provide summary reports for the submission based on the FDA guidance and standards. Utilizing guidance documents for a particular device sets up the baseline for the submission of the device to the FDA. It is a best practice to include a summary report on how the guidance was utilized to demonstrate the device is a substantial equivalent. Special controls are a way of assuring that a class II device is safe and effective. Any special controls for the device will be listed in the device classification regulation in 21 CFR parts 862 through 8921.
The last critical part when submitting an abbreviated 510K is to recognize the Voluntary Consensus Standards that are associated with the specific device. These standards may be found in the associated guidance documents for the device or additional regulatory standards. The FDA guidance for Abbreviated 510Ks states to include data and supporting information that supports how the voluntary consensus standard was utilized in the submission1.
If the formatting for an abbreviated 510K does not meet the FDA requirements, the FDA could reject the abbreviated 510K. The submission may be converted to a traditional 510K however more information is usually required. If your company needs assistance with the determination of which 510K submission to complete or submitting a 510K overall EMMA International is here to help. Contact us by phone at 248-987-4497 or by email at firstname.lastname@example.org.
1FDA (May 2022) How to Prepare an Abbreviated 510K, retrieved on June 21, 2022, from https://www.fda.gov/medical-devices/premarket-notification-510k/how-prepare-abbreviated-510k