The 2019 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, 2019, regulations included are:
- Title21: Food and Drugs
- FDACode 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)
The convenient and easy-to-reference pocket guide is ideal for new hire packets, giveaways, IRBs, regulatory personnel, QA/QC departments, institutions, CROs, sponsors, investigator meetings, research facilities, hospitals conducting clinical research and more!
Significant updates to the 2019 edition include:
- §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.
Updates this year include the fully revised International Conference on Harmonization E6 R2 guideline, which has significant implications for industry. Key changes include:
- The required implementation of a risk-based quality management plan approach (i.e.risk management/risk-based quality management)
- More efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results
- Other requirements that demand that new knowledge, skills and abilities are acquired and implemented
Ensure that you and your teams are aware of these changes!
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