Source: https://www.barnettinternational.com/cfr-ich-gcp-reference-guide-for-medical-devices-2018-1
Timestamp: 2019-04-25 08:08:20+00:00

Document:
The 2018 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.
§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.
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