What's New at CBER Update

This page has been updated recently. 

• Unique Device Identification: Direct Marking of Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 587KB) 
  Posted: 6/23/2015
• Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Draft Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff (PDF - 877KB) 
  Posted: 6/23/2015