Resources

The medical device world changes almost daily. That's why we have assembled critical information in a variety of forms—white papers, videos, podcasts, reports and more.

Xavier Training - Presentations

• Purchasing Controls Symposium
  February 7, 2012
  • Industry Presentation
  • FDA Presentation

FDA Path Forward

• "Institute of Medicine Report: The FDA 510(K) Clearance Process at 35 Years"
• CDRH Plan of Action for 510(K)
• CDRH 2011 Strategic Priorities
• FDA Strategic Priorities: 2011 - 2015
• FDA Science Report Recommendations
• Pathway to Global Product Quality and Safety - FDA 2011 Report
• Food Safety Modernization Act: The new legislation represents a major reform of the food safety provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and significantly expands the powers of the Food and Drug Administration (FDA) with respect to food.
• After Heparin: Pew Report
• MDUFA Minutes from FDA Meetings: Features what is FDA's future 510(k) process, timing and fees will be.

The Foundation You Need

• CDRH Data
• Enforcement Statistics
• CDRH Learn: FDA’s Center for Devices and Radiological Health (CDRH) page for industry education. Find out more »

Webinars

• FDASIA for the Medical Device Industry