Nobles Medical Technology II, Inc.

Warning LetterOpen

Anthony A. Nobles, PhD Chairman and CEO Nobles Medical Technology II, Inc. 17072 Newhope Street Fountain Valley , CA 92708 United States anobles@noblesmedical.comFEI 3002690289Issued Jan 26, 2024Center for Devices and Radiological Health

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Violations3

Issue DateJan 26, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Nobles Medical Technology II, Inc.
Location: Anthony A. Nobles, PhD Chairman and CEO Nobles Medical Technology II, Inc. 17072 Newhope Street Fountain Valley , CA 92708 United States anobles@noblesmedical.com
FEI Number: 3002690289
Country: United States
Issue Date: January 26, 2024
Issuing Office: Center for Devices and Radiological Health
Product Type: Drugs
Status: Open

Summary

Nobles Medical Technology II, Inc. was cited for serious violations of investigational device exemption (IDE) regulations (21 CFR Part 812) during an FDA inspection of their NobleStitch EL clinical study, a device intended to close patent foramen ovale and prevent recurrent ischemic stroke. The inspection, conducted by the FDA's Office of Bioresearch Monitoring Operations from October 16-20, 2023, identified objectionable conditions related to sponsor activities and procedures that failed to comply with applicable federal regulations governing clinical investigations. The violations raised concerns about the scientific validity and accuracy of study data as well as the adequacy of human subject protections in the significant risk clinical trial.

Nobles Medical Technology II, Inc. FDA Warning Letter, January 26, 2024