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
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 »
- FDA/Xavier MedCon
- MedCon 2012
- MedCon 2011
- MedCon 2010