FDA EIR - Tusker Medical, Inc. - October 08, 2019

An FDA Bioresearch Monitoring inspection of Tusker Medical, Inc. in Menlo Park, CA, was conducted from October 2-8, 2019. The inspection focused on the company's compliance as a sponsor for the clinical trial "OTTER" (Protocol CPR007001 Rev E), evaluating the "Lidocaine/Epinephrine Iontophoresis and Automated Tympanostomy Tube Insertion System" under Premarket Application P190016.

The inspection identified three primary observations. Firstly, proper monitoring for the investigational study was not ensured, as Tusker Medical failed to develop a Clinical Monitoring Plan prior to study commencement, and many monitoring visit reports were submitted beyond the required 30-day timeframe. Secondly, several monitors selected did not meet the company's internal qualification of a "Bachelor's degree or equivalent in a scientific discipline" for a Sr. Clinical Research Associate. Thirdly, investigational devices were shipped to a principal investigator prior to site Institutional Review Board (IRB) approval and device ship authorization. These findings indicate non-compliance with regulatory obligations for medical device clinical trials.

Tusker Medical, Inc. was formally notified of these observations on a FORM FDA 483 and was required to submit a written response to the FDA within 15 business days for consideration in regulatory action.