Guide To Medical Device Regulations

Print Edition - Guide to FDA Medical Device Regulations: 2013 Edition

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May 2013
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Stay up to date on more than two dozen key medical device regulation changes with the 2013 edition of FDAnews’ Guide to FDA Medical Device Regulationsthe most authoritative and comprehensive guide ever assembled. Order it now to understand what your organization must do to satisfy the FDA and achieve success.

We’ve followed the changes so you don’t have to. From a comprehensive overview of the FDA’s regulatory framework for medical devices … to registering … to avoiding regulatory and compliance issues … to postmarket obligations, the Guide to FDA Medical Device Regulations offers everything you need to know in one searchable package.

Order the Guide now to get new information on the changes concerning:

  • FDA and industry procedures for Section 513g requests
  • FDA and industry actions on Premarket Notification (510(k)) submissions
  • Medical device user fees for small business qualification and certification
  • Inspection of medical device manufacturers
  • User fees and refunds for premarket approval applications and device biologics license applications
  • And much more actionable information


There’s a reason this is an FDAnews best-seller. The 2013 Guide to FDA Medical Device Regulations includes full texts of every device-related regulation, plus executive summaries and analyses that will help your company avoid regulatory issues, 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:

  • Premarket submissions
  • Inspection procedures
  • Reporting and tracking
  • Labeling
  • FDA priorities for future regulatory initiatives
  • Device registration fees from 2013 to 2017
  • Fee waivers and extensions
  • FDA criteria for clinical investigations
  • Incorporating human factors engineering into risk management
  • Software validation
  • Adding URLs to electronic labeling
  • Unique device identification system requirements
  • Post-approval studies imposed by PMA order

The Only Choice for Device Companies
Intended for compliance and regulatory affairs professionals, quality assurance staff, design and development staff, and managers who want to assure the success of their companies, the Guide to FDA Medical Device Regulations 2013 will keep you current and help you plan for tomorrow's challenges in ways that can increase profitability and reduce risk.

The 2013 Guide to FDA Medical Device Regulations is available in print or PDF format.

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