Guide to FDA Medical Device Regulations: 2015 Edition

Washington, D.C. – Whether you need to help your company convince the FDA to accept a predicate device in a simple 510(k) filing or you're responsible for implementing 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 in the Guide to FDA Medical Device Regulations: 2015 Edition.

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 your company 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

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.

Source: FDANews