Whom should I consult when I have questions about the manufacturing regulations or the conduct of a study (e.g., human subject protection issues)?
(CDRH) For questions regarding manufacturing regulations and IVD-specific conduct of studies, contact: Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Regulatory Staff, Patient Safety and Product Quality – Phone: (240) 276-0484 For questions regarding the conduct of studies, contact: Office of Compliance (OC) Division of Bioresearch Monitoring (DBM) Phone: (240) 276-0125 or Investigational Device Exemptions (IDE) Staff Office of Device Evaluation Phone: (240) 276-4040 Center for Biologics Evaluation and Research (CBER) For questions regarding manufacturing regulations, contact the appropriate reviewing division identified in the previous answer.
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