1. Update on the National Postmarket Surveillance System
Danica Marinac- Dabic MD, PhD
Director, Division of Epidemiology 1 1 1

2. FDA’s Current Surveillance System Four Key Proposed Actions
Outline
Background
Vision
FDA’s Current Surveillance System
Four Key Proposed Actions
Public Engagement 2

3. Postmarket Surveillance: Background
High-profile postmarket issues underscore weaknesses, challenges
ICDs, metal-on-metal hip implants, etc.
IOM Report recommended FDA develop comprehensive medical device postmarket strategy
Devices pose unique challenges as compared to drugs/biologics 3

4. Postmarket Surveillance: Background
Current system often seen as inefficient, costly, slow:
Patients needlessly exposed to preventable adverse events
Mandated manufacturer studies are inefficient and expensive
Fails to leverage postmarket data to facilitate development of new devices and new uses of existing device 4

5. FDA’s Vision for National System
Communicates timely, accurate, systematic, and prioritized assessments of device benefits and risks throughout their marketed life using high quality, standardized, structured, electronic health information (EHI)
Identifies potential safety signals in near real- time from variety of privacy-protected data sources
Reduces burdens and costs of medical device postmarket surveillance
Facilitates clearance and approval of new devices or new uses of existing devices 5 5

7. Public Engagement
Issued Strengthening Our National System for Medical Device Postmarket Surveillance September 7, 2012
Roll-Out
Draft report posted on CDRH web site
Received Comments
Web site provided form
Held Public Meetings
Postmarket Plan (September 10)
MDEpiNet Workshop (September 11)
Registries Workshop (September 12 and 13)

8. Proposed Specific Actions to Strengthen Device Postmarket Surveillance
Establish a UDI System and Promote the Incorporation of UDI into Electronic Health Information
UDI critical for various surveillance efforts (including attributes)
UDI critical to leveraging distributed data sources
Promote the Development of National and International Device Registries for Selected Products
Critical in development of proof-of-concept active surveillance efforts
Need to be linked to other longitudinal data sources for effective ongoing and prospective surveillance

9. Proposed Specific Actions to Strengthen Device Postmarket Surveillance
Modernize Adverse Event Reporting and Analysis
Automated methods may enhance reporting and case ascertainment
Bi-directional surveillance may amplify potential signals
Develop and Use New Methods for Evidence Generation, Synthesis, and Appraisal
Surveillance operating characteristics vary by study design, parameter specification, and data source
Need to understand and account for learning curve effects

10. MDEpiNetMDEpiNet MDEpiNet MDEpiNetMDEpiNetMDEpinet
PARTNERSHIP
METHODOLOGY
INFRASTRUCTURE
TPLC
GLOBAL

11. Next Step Release the Implementation Plan
Work with partners/stakeholders to align, leverage and promote national and international infrastructure

12. Thank you!
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