2. Office of Surveillance and
Biometrics: Basic Functions
Premarket review
Statisticians
Epidemiologists
Signal detection via monitoring tools
including MDR, MedSun
Risk characterization (analysis)
Coordination of nonregulatory
response
Interpretation of MDR regulation
3. Boston Scientific Expands Recall
Boston Scientific Stent of Troubled Stent
Recall Grows to 96K Units
FDA won't expand recall of stents
Drug-coated stents may face
additional FDA scrutiny
FDA Is Reviewing
Reports of Trouble With
Taxus Stent
Boston Scientific's Older Stents
Draw FDA Temperature
Scrutiny of FDA up over Cordis
FDA Advises Physicians of Adverse Events
Associated with Cordis Cypher Coronary Stents
4. Pre-Postmarket Balance
Use premarket data to make initial
decisions about safety and
effectiveness and gain understanding
of device benefits and risks
Use postmarket data to improve our
understanding of the risk benefit
profile; disseminate timely safety
information or take regulatory action
as appropriate
5. Need for Postmarket Studies
and Surveillance
Limited size of premarket studies cannot detect or
characterize events that occur at a low rate
Need for long term follow-up (issues of
durability/biocompatibility etc.)
Use error
Use of device in community practice or home care
Concerns for selected patient groups
Device/device or device/drug interactions
Device failure
Off label use
6. Condition of Approval Studies
Immediate Postapproval Concerns
Postapproval requirements can
include
“continuing evaluation and periodic
reporting on the safety, effectiveness,
and reliability of the device for its
intended use.” 21 CFR 814.82 (a) (2).
7. Indications for CoA Studies
Need to refine risk estimates or better
characterize safety issues, particularly
uncommon and serious
Need to study specific population
subgroups
Need to study long term effects
Need to study use of device under
conditions of general use
8. CoA Quality Study: 2002-3
1998 through 2000: 127 PMAs
approved with 45 CoA orders.
CDRH had limited procedures for
tracking progress or results
Turnover of lead reviewers resulted in
lack of follow-up
No results received for 22%
Two studies had not been started at
all
9. Strategy for Change
Transfer CoA tracking and follow-up
to OSB
Develop and institute automated
tracking system
Acknowledge the receipt of study
reports
Follow-up when reports are not
received
10. Strategy for Change
Add epidemiologist to PMA review
team
Tasked with the development of a
postmarket monitoring plan
Lead design of postmarket study
development
Lead the development of well
formulated postmarket questions
Lead in evaluation of study progress
and results
Will continue to work with PMA team
11. Strategy for Change
Develop guidance for industry and
FDA to provide clear guidelines for
content, format and due dates
Periodically report the results of CoA
to Advisory Panels
CDRH may post periodic status
reports of CoA on Agency website
12. Least burdensome
Approach
Least burdensome principles apply
Acknowledged in FDA guidance
“integrated in premarket…, as well as
postmarket…as they relate to
premarket…
The “way” to Least burdensome is to
discuss pre/postmarket balance as
early as possible in the approval
process.
13. Elements of Protocols for
Analytic Studies
Study objective – reason for doing the
study
Define study group
Outcomes of interest – safety issues
Study design and procedures
Study size
Analysis plan
Reporting requirements
14. Elements of Protocols for
Analytic Studies
Our goal is to have these elements of
the study protocol agreed upon before
product approval.
15. Adverse Event Reporting
Medical Device Reporting (MDR)
Approximate 130k reports/year
Half are Summary Reports
After initial triage, individual reports are
monitored by analysts
Look for rare, unexpected events, increase
in events, seriousness of event, population
affected, preventability
Summary reports are monitored for change
in trends
Primarily manufacturer reports (90%)
17. Medical Device Safety Network
(MedSun)
300 hospitals and other facilities trained to
recognize and report device related adverse
events; goal to reduce barriers to reporting
Reports include “close calls”; emphasis on
prevention
Provides CDRH with connection to device
users
Reports and actions tend to focus on user
issues, “everyday safety issues”
Provides laboratory for quick surveys and
other research projects
18. Postmarket Surveillance:
Section 522
Allows CDRH to order postmarket
surveillance studies for:
Class ll or Class lll products
Intended to be implanted for more
than one year, or
Life sustaining/life supporting and
used outside user facility, or
Failure would likely cause serious
health consequences
19. Postmarket Surveillance:
Section 522
CDRH poses public health question to
industry
Industry develops plan to address
question
Wide variety of study methods
acceptable
Generally limited to three year studies
20. Other Surveillance Tools
Observational Studies – de novo or
existing cohorts
Medical care claims data
Registries – real world use
International vigilance
Rapid Response surveys
21. Future Directions
Goal: To improve our postmarket
toolkit to allow us to make
reasonable science-based
decisions in evaluating the
benefits and risks of medical
devices
