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# Four 510(k) Guidances Out
- URL: https://www.fdaweb.com/four-510-k-guidances-out/
- Published: 2019-09-12T12:00:00.000Z
- Updated: 2026-09-15T01:49:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144985

FDA has published four guidances relating to aspects of the 510(k) pathway for medical devices. The first, *The Special 510(k) Program*, gives the agency’s current thinking on 510(k)s that are appropriate for review as a Special 510(k). The [document](https://www.fda.gov/media/116418/download?ref=fdaweb.com) says it describes 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, in addition to other 510(k) content requirements, the basis for substantial equivalence. The guidance clarifies the types of technological changes appropriate for review as Special 510(k)s.

The second guidance, *Format for Traditional and Abbreviated 510(k)s*, focuses on providing guidance on how to format an original submission for a traditional or abbreviated 510(k) submission. The [document](https://www.fda.gov/media/130647/download?ref=fdaweb.com) provides a general framework for the content and format of a traditional or abbreviated 510(k) and does not describe agency recommendations for any specific device types, Special 510(k)s, PMAs, HDEs, de novo requests, or IDE applications. FDA says it believes the guidance’s recommendations will conserve agency and industry resources and facilitate timely review.

A third guidance, *The Abbreviated 510(k) Program*, gives recommendations on an optional approach that may be used to demonstrate substantial equivalence in 510(k)s. The [document](https://www.fda.gov/media/72646/download?ref=fdaweb.com) says the abbreviated program uses guidance documents, special controls, and/or voluntary consensus standards to facilitate FDA’s premarket review of 510(k) submissions. The approach is said to be intended to facilitate 510(k) submission preparation by manufacturers and review by FDA. The agency says it believes the program may conserve industry and agency resources, while still protecting public health, and not altering the statutory criteria for substantial equivalence.

Finally, *Refuse to Accept Policy for 510(k)s*, explains the procedures and criteria FDA will use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review. The [document](https://www.fda.gov/media/83888/download?ref=fdaweb.com) says that focusing FDA review resources on complete submissions will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible. The guidance was originally issued 5/20/1994 and supersedes one issued 2/21/19.