The 2017CFR/ICH Reference guide 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, 2017, 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!
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
Significant updates to medical device regulations regarding labeling, exemptions, and definitions, including:
- Prominence of label statements
- Exemptions from adequate directions for use regarding prescription devices
- Exemptions from premarket notification
- The definition of a custom device
Ensure that you and your teams are aware of these changes!
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4”x7” perfect or spiral bound soft cover pocket guide.