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# Draft Guide on Expanded Abbreviated 510(k) Program
- URL: https://www.fdaweb.com/draft-guide-on-expanded-abbreviated-510-k-program/
- Published: 2018-04-12T12:00:00.000Z
- Updated: 2026-09-14T23:58:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141212

*Federal Register* notice: FDA has made available a draft guidance entitled “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria.” The document describes an optional program for certain well understood device types, where a submitter could demonstrate that a new device meets FDA-identified performance criteria instead of directly comparing the performance of the new device to a specific, submitter-identified predicate device as part of a demonstration of substantial equivalence. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-04-12/pdf/2018-07564.pdf?ref=fdaweb.com).