FDA Warns Entellus Medical Over Serious Violations for Its Xpress Sinus Dilator Pediatric Trial
The FDA sent a warning letter to Entellus Medical (NSDQ:ENTL) over its failure to prevent physicians from violating the approved protocol for a pediatric trial of its Xpress sinus dilator.
The April 6 letter, published online this week by the federal safety watchdog, stems from an inspection that began exactly a year ago of a Plymouth, Minn., Entellus plant that the FDA conducted to review the company’s procedures in sponsoring the pediatric Xpress study.
The inspection found “serious violations” of regulations covering investigational device exemptions and the protection of human subjects, involving use of the Xpress dilator in patients under age 12 in frontal and sphenoid sinuses; the trial’s approved protocol only allowed treatment in the maxillary sinus for patients that young, according to the letter.
The April 6 letter, published online this week by the federal safety watchdog, stems from an inspection that began exactly a year ago of a Plymouth, Minn., Entellus plant that the FDA conducted to review the company’s procedures in sponsoring the pediatric Xpress study.
The inspection found “serious violations” of regulations covering investigational device exemptions and the protection of human subjects, involving use of the Xpress dilator in patients under age 12 in frontal and sphenoid sinuses; the trial’s approved protocol only allowed treatment in the maxillary sinus for patients that young, according to the letter.