The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

Fundamentals of US Medical Device Regulations (2019, e-book)

E-books     Member: $150.00

Fundamentals of US Medical Device Regulations (2019, e-book) HiddenProductTag

>> View Table of Contents

Item Details:

Derived from the 11th edition of Fundamentals of US Regulatory Affairs, this book focuses on US medical device legislation and regulations. It also examines the history of food, drug and cosmetic law in the US and the regulatory pathways available for all healthcare product submissions. 

Both devices and in vitro diagnostics (IVDs) are included in this volume, with chapters on:

  • clinical trials
  • Good Manufacturing Practices and quality system design
  • medical device submissions
  • medical device compliance and postmarketing activities
  • IVD submissions and compliance 
  • device and IVD advertising, promotion and labeling
Who Should Use This Publication?
Fundamentals of US Regulatory Affairs is designed for regulatory professionals working on products for the US market at all levels with a focus on medical devices. Whether you’re new to the profession or a veteran, you’ll find valuable information in the carefully curated pages.

Studying for the RAC? Take a look at our RAC prep resources.

Check out RAPS Fundamentals Series.

Group Rates
E-books are for individual use only. For information on group rates or site licenses please contact Jill Yager.

ISBN: 978-1-947493-35-3
Published by RAPS © 2019. E-Book 208 pages.

Search for Related Content

Medical Devices North America Compliance