Postmarket Surveillance: Medical DevicesSusan Gardner, PhDDirector, Office of Surveillance and Biometrics, CDRHFDLI Annual Meeting 4/08/05

Office of Surveillance and Biometrics: Basic Functions

Premarket reviewStatisticiansEpidemiologists

Signal detection via monitoring tools including MDR, MedSunRisk characterization (analysis)Coordination of nonregulatory responseInterpretation of MDR regulation

Boston Scientific Stent Recall Grows to 96K Units

FDA Is Reviewing Reports of Trouble With

Taxus StentBoston Scientific's Older Stents

Draw Scrutiny of FDA

Boston Scientific Expands Recall of Troubled Stent

FDA won't expand recall of stents

FDA Temperature up over Cordis

Drug-coated stents may face additional FDA scrutiny

FDA Advises Physicians of Adverse Events Associated with Cordis Cypher Coronary Stents

Pre-Postmarket Balance

Use premarket data to make initial decisions about safety and effectiveness and gain understanding of device benefits and risksUse postmarket data to improve our understanding of the risk benefit profile; disseminate timely safety information or take regulatory action as appropriate

Need for Postmarket Studies and Surveillance

Limited size of premarket studies cannot detect or characterize events that occur at a low rateNeed for long term follow-up (issues of durability/biocompatibility etc.)Use errorUse of device in community practice or home care Concerns for selected patient groupsDevice/device or device/drug interactionsDevice failureOff label use

Condition of Approval StudiesImmediate 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).

Indications for CoA Studies

Need to refine risk estimates or better characterize safety issues, particularly uncommon and seriousNeed to study specific population subgroupsNeed to study long term effectsNeed to study use of device under conditions of general use

CoA Quality Study: 2002-3

1998 through 2000: 127 PMAs approved with 45 CoA orders. CDRH had limited procedures for tracking progress or resultsTurnover of lead reviewers resulted in lack of follow-upNo results received for 22%Two studies had not been started at all

Strategy for Change

Transfer CoA tracking and follow-up to OSB

Develop and institute automated tracking systemAcknowledge the receipt of study reportsFollow-up when reports are not received

Strategy for Change

Add epidemiologist to PMA review team

Tasked with the development of a postmarket monitoring planLead design of postmarket study developmentLead the development of well formulated postmarket questionsLead in evaluation of study progress and resultsWill continue to work with PMA team

Strategy for Change

Develop guidance for industry and FDA to provide clear guidelines for content, format and due datesPeriodically report the results of CoA to Advisory PanelsCDRH may post periodic status reports of CoA on Agency website

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.

Elements of Protocols for Analytic Studies

Study objective – reason for doing the studyDefine study groupOutcomes of interest – safety issuesStudy design and proceduresStudy sizeAnalysis planReporting requirements

Elements of Protocols for Analytic Studies

Our goal is to have these elements of the study protocol agreed upon before product approval.

Adverse Event Reporting

Medical Device Reporting (MDR)Approximate 130k reports/yearHalf 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, preventabilitySummary reports are monitored for change in trends Primarily manufacturer reports (90%)

MDR Reports: 1998-2004

020000400006000080000

100000120000140000160000180000

1998 2000 2002 2004

IndividualSummaryTotal

Medical Device Safety Network (MedSun)

300 hospitals and other facilities trained to recognize and report device related adverse events; goal to reduce barriers to reportingReports include “close calls”; emphasis on preventionProvides CDRH with connection to device usersReports and actions tend to focus on user issues, “everyday safety issues”Provides laboratory for quick surveys and other research projects

Postmarket Surveillance: Section 522

Allows CDRH to order postmarket surveillance studies for:

Class ll or Class lll productsIntended to be implanted for more than one year, orLife sustaining/life supporting and used outside user facility, orFailure would likely cause serious health consequences

Postmarket Surveillance: Section 522

CDRH poses public health question to industryIndustry develops plan to address questionWide variety of study methods acceptableGenerally limited to three year studies

Other Surveillance Tools

Observational Studies – de novo or existing cohortsMedical care claims dataRegistries – real world use International vigilance Rapid Response surveys

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