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
Latest from Today's Medical Developments
- NextDent 300 MultiJet printer delivers a “Coming of Age for Digital Dentistry” at Evolution Dental Solutions
- Get recognized for bringing manufacturing back to North America
- Adaptive Coolant Flow improves energy efficiency
- VOLTAS opens coworking space for medical device manufacturers
- MEMS accelerometer for medical implants, wearables
- The compact, complex capabilities of photochemical etching
- Moticont introduces compact, linear voice coil motor
- Manufacturing technology orders reach record high in December 2025
