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CFR/ICH GCP Reference Guide for Medical Devices 2020 - Team 10-Pack
The 2020 CFR/ICH Reference Guide for Medical Devices provides the critical information you need to know to stay current with the medical device and combination product industry’s codes and regulations.
The compact nature of the guide offers an easy way to keep key device regulations right at your fingertips and readily available for quick reference. Updated as of April 1, 2020, regulations included are:
- Title21: Food and Drugs
- FDA Code of Federal Regulations, Good Clinical Practice Parts 11, 50, 54, 56
- Medical Devices and Quality System Parts 801, 803, 806, 807, 812, 814, 820, 822
- Product Jurisdiction (Combination Products) Part 3
- ICH Guidelines Good Clinical Practice (E6 R2)
Significant updates to the 2020 edition included:
- The update of websites and references of importance to clinical researchers
Significant updates to the 2019 edition included:
- §807.87 Information required in a premarket notification submission, regarding statements of human subject protection in submissions that include clinical data from investigations, conducted both inside and outside the US.
- Part 812 – Investigational Device Exemptions, including new definitions for independent ethics committees and retention periods, and acceptance of data from clinical investigations conducted outside the US.
- Part 814 – Premarket Approval of Medical Devices, regarding “pediatric patient” and “readily available” parameters, and entirely revised language in §814.15 Research conducted outside the United States, and §814.20 Application.
- Significant changes to the definitions and parameters for Humanitarian Use Devices, including §814.100 Purpose and scope, §814.102 Designation of HUD status, and §814.104 Original applications.
- §814.124 Institutional Review Board requirements, new definitions for IRB approval and withdrawal of IRB approval.
- The fully revised International Conference on Harmonization E6 R2 guideline, which has significant implications for industry.
Ensure that you and your teams are aware of these changes!
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