CFR ICH GCP Reference Guide for Medical Devices 2017 (Spiral)

Barnett International Publication

 CFR Medical Devices 2017

The 2017 CFR/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:


  •  Title 21: 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)  


    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!

    What’s New?

    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!

    Custom and Multiple copy discounts are available. Call 1 800 856 2556 or email 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.