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# Issues Raised on 510(k) Change Guidance
- URL: https://www.fdaweb.com/issues-raised-on-510-k-change-guidance/
- Published: 2016-11-08T12:00:00.000Z
- Updated: 2026-09-14T21:46:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137289

Johnson & Johnson says it commends FDA for creating a comprehensive and thoughtful draft guidance on when a 510(k) is necessary when implementing changes to a previously cleared 510(k) device containing software. “We particularly appreciate the collaborative approach that FDA demonstrated during the development of this document,” it says in its comment [letter](https://www.regulations.gov/document?D=FDA-2016-D-2021-0013&ref=fdaweb.com). J&J generally aligns itself with comments submitted by AdvaMed, and especially that organization’s comments related to slight modifications to several examples that it says would bring more clarity.

AdvaMed’s letter [says](https://www.regulations.gov/document?D=FDA-2016-D-2021-0012&ref=fdaweb.com) it is pleased that FDA has recognized and defined the role the Quality System Regulation can play in assuring there are processes in place to evaluate and document changes to a marketed device. It says it supports the use of risk management principles in determining the effect of a device change. But it expresses concern that the concept of applying risk management in assessing the impact of a change to the device is inconsistently applied throughout the document. AdvaMed also says it is concerned about the Labeling Changes section in the draft where the “significantly affect safety or effectiveness” test is applied to the question of change in intended use. The organization also submitted specific line-by-line comments.

Abbott submitted [comments](https://www.regulations.gov/document?D=FDA-2016-D-2021-0010&ref=fdaweb.com) on the draft’s Labeling section, general versus specific use, cumulative review of changes, listing changes and internal documentation, components and use of the term in the guidance, and the need to clarify level of specificity when in a device-specific guidance or regulation.

The 510(k) Coalition [says](https://www.regulations.gov/document?D=FDA-2016-D-2021-0007&ref=fdaweb.com) the draft “exemplifies a strong step forward in clarifying FDA’s thoughts on when a modification would trigger a new 510(k) to be submitted on behalf of a sponsor. It is critical that when this guidance is finalized, the criteria for when to submit a new 510(k) for a modification is the regulatory standard of a change that is a major change in intended use (and this term should be used) or is a change that could significantly affect safety or effectiveness.”

Finally the Medical Device Manufacturers Association [says](https://www.regulations.gov/document?D=FDA-2016-D-2021-0017&ref=fdaweb.com) it appreciates that the draft guidance builds on the structure of the K-97 guidance that has been in place for 20 years and looks to provide greater clarity on that guidance. It associates itself with comments from the 510(k) Coalition and highlights its areas of greatest concern that must be addressed before the guidance is finalized as cumulative changes, labeling changes, and risk management.