Drug & Device Defense Forum


The Hub
2929 Arch St 
Philadelphia, PA 19104

Date & Time

Start Date: 12/13/2016
Start Time: 8:30am
End Time: 6:15pm


Abby Sacunas, a member of Cozen O'Connor's Products Liability practice, will be speaking at this event in Philadelphia. Abby will be speaking on a panel called 'New FDA Guidance For Medical Device Manufacturers and What It Means For Your Business.'

This presentation will focus on three inter-related recent announcements from the FDA:

  • Benefit-Risk Factors Considered in Compliance Determinations for Approved Products
  • Benefit-Risk Factors Considered in Pre-Market Assessments
  • Modifications to the Unique Device Labeling Rule