FDA EIR - Joseph McCready, MD - May 09, 2017

An FDA inspection was conducted at Joseph McCready, MD (AMRI of Tucson) from May 1-9, 2017, to evaluate compliance with regulations for clinical investigations, particularly Good Clinical Practices and requirements for investigational medical devices. The inspection focused on studies involving the Magnetic Molecular Energizer (MME) device. The FDA issued a three-item Form 483, detailing significant issues: The clinical investigation of the MME device, classified as non-significant risk, did not meet all required exemptions for investigational devices. This included a lack of Institutional Review Board (IRB) approval and annual oversight for one study protocol dating back to 2005. Furthermore, the firm's website and brochure made unproven claims of the MME device's safety and effectiveness, and a required specimen collection was not consistently performed for all subjects in one study. The informed consent document for a specific study was deficient, lacking a description of reasonably foreseeable risks or discomforts to study participants. Finally, the same informed consent document failed to include a statement outlining the conditions under which an investigator could terminate a subject's participation, irrespective of their consent. These observations indicated non-compliance with federal regulations governing investigational devices and human subject protection. Although Dr. McCready acknowledged the observations, he did not commit to providing a written response with corrective actions within the specified timeframe. An FDA reviewer also provided Dr. McCready with information regarding agency communications to the study's sponsor about study continuation.