Standardization & Quality Control️

Translational Resource Center’s Standardization & Quality Assurance services provide guidance to establish quality frameworks from the outset, including for non-regulated preclinical study protocols. We strive for improved study design by including appropriate controls such as blinding, and randomization and ensuring robust and reproducible data.

Contact translationalrc@umich.edu for more information.

Compendium of FDA Regulations and Guidance

• 21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies
• FDA Guidance: Questions and Answers on Good Laboratory Practice
• FDA Compliance Program Guidance Manual 7348.808 Good Laboratory Practice
• 21 CFR Part 812: Investigational Device Exemptions
• 21 CFR Part 814: Premarket Approval of Medical Device
• 21 CFR Part 820: Quality System Regulation
• FDA Guidance: Design Control Guidance for Medical Device Manufacturers
• 21 CFR Part 312: Investigational New Drug Application
• FDA Guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
• FDA Guidance: Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices – Part: Evaluation and Testing within a Risk Management Process”
• FDA Guidance: Preclinical Assessment of Investigational Cellular and Gene Therapy Products
• FDA Guidance: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
• FDA Guidance: General Considerations for Animal Studies for Medical Devices
• FDA Guidance: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]