> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# MDSAP Nonconformity Grading System Guidelines
- URL: https://www.fdaweb.com/mdsap-nonconformity-grading-system-guidelines/
- Published: 2021-09-08T12:00:00.000Z
- Updated: 2026-09-14T17:13:39.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150104

FDA’s Medical Device Single Audit Program (MDSAP) has released a document, *Guidelines on the Use of Quality Management System—Medical Devices—Nonconformity Grading System for Regulatory Purposes and Information Exchange*. The [guideline](https://www.fda.gov/media/152034/download?ref=fdaweb.com) is intended for regulatory authorities and auditing organizations participating in or using the results of the MDSAP. It discusses a rating system for nonconformities to support the exchange of information about nonconformities from audit findings that go beyond the binary concept of “major” and “minor” to a five-level grading system of nonconformities.