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# Medical Device Study Site Violations
- URL: https://www.fdaweb.com/medical-device-study-site-violations/
- Published: 2017-09-05T12:00:00.000Z
- Updated: 2026-09-14T22:46:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139538

A 9/6-9/27/Entellus Medical, Plymouth, MN, found “objectionable activities” in the firm’s role as sponsor of a significant risk study of the XprESS Multi-Sinus Dilation System and the Path Assist Confirmation Tools conducted under an IDE, according to a just-released 4/6 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574496.htm?ref=fdaweb.com). Specific violations noted on an FDA-483 were: 

- failing to secure compliance with investigators who are not complying with the signed agreement or investigational plan and the institutional review board (IRB) approved protocol;
- failing to obtain approval of a supplemental application and IRB approval prior to implementing a change to the investigational plan;
- failing to promptly inform the reviewing IRB and FDA of significant new information about the investigation; and
- failing to have both IRB and FDA approval of an application n or supplemental application before beginning an investigation or part of an investigation.

Entellus was told to respond with a correction plan with completion dates for each action to be accomplished as well as a plan for monitoring the effectiveness of the corrective actions.