Matthew N. Songer, MD – FDA Warning Letter, Apr 22, 2010

This Warning Letter details objectionable conditions observed during an FDA inspection of Orthopaedic Surgery Associates (OSA) from April 19-22, 2010, regarding the "NuBac? Disc Arthroplasty" clinical study (IDE (b)(4)). The inspection aimed to ensure data validity, accuracy, and human subject protection.

Violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects) were identified. Key deficiencies include:

1. **Failure to include all elements of informed consent (21 CFR 50.25(a) and 50.25(b)):** The "Pioneer NUBAC: MGH: November 11, 2008" Informed Consent Document (ICD) used for all ten subjects lacked statements about the study being research, identification of experimental procedures, unforeseeable risks (especially regarding x-rays/MRIs and potential harm to embryo/fetus), voluntary participation/withdrawal rights, and contact information for questions about research/subjects' rights. Corrective action requires a revised, IRB-approved ICD, documentation of IRB approval, and a plan to inform existing subjects.

2. **Failure to conduct the investigation according to the signed agreement/investigational plan (21 CFR 812.110(b)):** Seven out of (b)(