CFR ICH GCP Reference Guide for Medical Devices 2018 (Spiral)
$17.95
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.
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, 2018, 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!
Recent Updates:
- 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
the 2018 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.
Ensure that you and
your teams are aware of these changes!
Custom and Multiple
copy discounts are available. Call 1 800 856 2556 or email customer.service@barnettinternational.com for custom and
bulk orders.
Standard orders of
100+ books are only $12.95 per book!
This book can also be
customized with your company logo of 100+ books. Call for details.
4”x7” perfect or
spiral bound soft cover pocket guide.