FDA 483 - Mainstay Medical Limited US, Inc. - December 20, 2019

Mainstay Medical Limited US, Inc. in Minneapolis, MN, was cited for deficiencies as a sponsor of an investigational device study. The inspection revealed failures in submitting timely annual progress reports to IRBs and widespread issues in ensuring proper monitoring of the investigational study. These observations indicate a lack of adherence to regulatory requirements for clinical trial oversight and reporting.