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 info@emmainternational.com.

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

Sarah Koehler

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.

More Resources

FDA’s Refusal to Accept Process

FDA’s Refusal to Accept Process

Before the submission of a 510(k) premarket notification, the purpose of which is to notify the FDA of the manufacturer’s intent to market a medical device,[i] there is a provision for acceptance review. This review serves as a method to assess whether a submission is administratively complete and includes all necessary information for FDA to determine substantial equivalence under section 513(i) of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 United States Code (U.S.C.) § 360c(i)). To establish substantial equivalence under this provision, FDA must find the same intended use as the predicate device and either have the same technological characteristics as the predicate device or appropriate clinical and scientific data necessary to establish that the device is safe and effective as the predicate device. If the Authority is unable to determine substantial equivalence due to insufficient information, it may request for additional information to make that determination. Therefore, as a part of the acceptance review, the FDA staff follows the acceptance checklist[ii] to ensure that the application is administratively complete. These administrative elements are identified as RTA items and are required to be presented. The purpose of conducting the acceptance review is for the Lead Reviewer to determine whether the 510(k) submission meets the minimum threshold of acceptability and should be accepted for substantive review.[iii]
Empowering Your Workforce through Kaizen

Empowering Your Workforce through Kaizen

Last week, I touched on the idea of involving and empowering all employees in the workplace through the corrective and preventive actions process by fostering taking initiative and a problem-solving (refer to blogpost ‘The Art of Addressing Non-Conformances in Operations’). To expand on this concept a bit further, we’re going to be looking at Kaizen–a continuous improvement strategy in which employees at all levels are also empowered to solve problems towards big gains.
FDA’s draft guidelines on Remote Regulatory Assessments (RRAs)

FDA’s draft guidelines on Remote Regulatory Assessments (RRAs)

The pandemic has been a challenging time for all industries including the Food and Drug Administration (FDA). The FDA had to alter the manner in which it conducted its operations. One set of tools adopted by the FDA in response to COVID-19 was the remote regulatory assessment (RRAs).

Ready to learn more about working with us?

Pin It on Pinterest

Share This