Standardization & Quality Control
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)]
