> ## 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.

# Changes Sought in Establishment Inspection Guidance
- URL: https://www.fdaweb.com/changes-sought-in-establishment-inspection-guidance/
- Published: 2019-07-17T12:00:00.000Z
- Updated: 2026-09-15T01:38:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144548

AdvaMed says an FDA draft guidance on review and update of device establishment inspection processes and standards “should be risk-based and consider the participation of the subject company in international device audit programs.” The trade association’s 5/28 comment [letter](https://www.regulations.gov/document?D=FDA-2019-D-0914-0006&ref=fdaweb.com) also recommends that the draft guidance include criteria to assist agency investigators in maintaining uniform processes and standards, and that agency procedures should include metrics to measure success of the revised inspection processes.

When FDA extended the comment period on the draft guidance, AdvaMed submitted an additional [comment](https://www.regulations.gov/document?D=FDA-2019-D-0914-0007&ref=fdaweb.com) asking that the agency clarify the guidance to provide that the FDA Reauthorization Act of 2017 mandate that it implement consistent processes and standards for inspection of medical device establishments applies to inspection of any device or device component of a combination product, regardless of which Center has jurisdiction over the device.

Abbott’s [letter](https://www.regulations.gov/document?D=FDA-2019-D-0914-0008&ref=fdaweb.com) specifically asks that FDA clarify applicability of the document to devices subject to BLAs.