FDA WARNING_LETTER - Nobles Medical Technology II, Inc. - October 20, 2023

The FDA issued a Warning Letter to Nobles Medical Technology II, Inc. on January 26, 2024, following an inspection from October 16-20, 2023. The inspection assessed compliance as a sponsor for the "STITCH" clinical study (IDE G180296) of the NobleStitch EL device.

The letter cited serious violations of 21 CFR Part 812 (Investigational Device Exemptions). Key deficiencies include:

1. **Failure to ensure proper monitoring and IRB review/approval (21 CFR 812.40):** The firm failed to provide investigators with necessary information (signed protocols, brochures, labeling), ensure proper study monitoring, and provide documentation of IRB approvals and continuing review for multiple sites. 2. **Failure to select qualified investigators and monitors (21 CFR 812.43(a) and (d)):** The firm did not provide documentation (e.g., CVs) to show that clinical investigators or monitors were qualified by training and experience. 3. **Failure to obtain signed investigator agreements (21 CFR 812.43(c)(4)(i)):** Signed agreements lacked a statement of the investigator’s commitment to supervise all device testing involving human subjects. 4. **Failure to obtain financial disclosure information (21 CFR 812.43(