FDAnews Announces — New Book — Guide to FDA and EU Medical Device Regulations: 2017 Edition


Guide to FDA and EU Medical Device Regulations: 2017 Edition

**An FDAnews Book**


No matter on which side of the Atlantic devicemakers do business, this fully updated and expanded guide keeps them in touch with the medical device regulations they have to follow.

In addition to the full text of the FDA’s regulations in 21 CFR Parts 800 to 898, the 2017 Guide includes more than 150 FDA guidances for devicemakers, covering everything from acceptance and filing review of premarket approval applications to the unique device identification system.

The FDA has released more than 50 new guidances since publication of the 2015 Guide, including:

  • List of Highest Priority Devices for Human Factors Review
  • Reporting of Computational Modeling Studies in Medical Device Submissions
  • Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
  • Software as a Medical Device (SaMD): Clinical Evaluation
  • Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
  • FY 2017 Medical Device User Fee Small Business Qualification and Certification
  • Adaptive Designs for Medical Device Clinical Studies

Readers will find them all here.

Plus, readers will get the full text (more than 1,000 pages) of the European Union’s newly revised regulations for medical devices and in vitro diagnostic devices.

Published in PDF format, readers will be able to perform keyword searches on the entire (5,000+ pages) Guide as well as pick and choose the documents they need to reference and even print and disseminate them to their staff.

For newcomers and veterans alike, this is a must-have quick-reference encyclopedia.


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