FDAnews Bestseller Updated: Guide to FDA Medical Device Regulations — 2015 Edition

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Stay up-to-date on key medical device regulation changes with the most authoritative and comprehensive guide ever assembled. The 2015 Guide to FDA Medical Device Regulations includes full texts of every device-related regulation and guidance — included on a fully searchable CD — plus executive summaries and analyses that will help manufacturers avoid regulatory missteps, get to market faster and improve profitability.

Guide to FDA Medical Device Regulations — 2015 Edition
**FDAnews Publication**
http://www.fdanews.com/GuideToFDAMDRegs2015

Whether a manufacturers needs to convince the FDA to accept a predicate device in a simple 510(k) filing or implement UDI across a family of high-risk implantable devices, there’s one thing all regulatory professionals need. The most up-to-date, latest FDA regulations available.

That’s why the Guide to FDA Medical Device Regulations is an FDAnews best-seller.

The 2015 Guide includes full texts of every device-related regulation and guidance — included on a fully searchable CD — plus executive summaries and analyses that will help manufacturers avoid regulatory missteps, get to market faster and improve profitability. For newcomers and veterans alike, this is a must-have quick-reference encyclopedia.

Discover the changes and best practices regarding:

  •     Determining substantial equivalence of predicate devices
  •     Home use devices
  •     Cybersecurity requirements
  •     UDI
  •     De Novo classifications
  •     Expedited access for devices addressing unmet medical needs
  •     New Policy on General Wellness Devices
  •     Labelling
  •     And much more

Stay up-to-date on key medical device regulation changes with the 2015 edition of FDAnews’ Guide to FDA Medical Device Regulations — the most authoritative and comprehensive guide ever assembled.

Publication Details:
Guide to FDA Medical Device Regulations — 2015 Edition
**FDAnews Publication**
http://www.fdanews.com/GuideToFDAMDRegs2015

Format: Print or PDF
Price: $397

Easy Ways to Order:
Online:     http://www.fdanews.com/GuideToFDAMDRegs2015
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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