Presentation on theme: "Elizabeth Mansfield, PhD OIVD Public meeting July 19, 2010"— Presentation transcript:
1 Elizabeth Mansfield, PhD OIVD Public meeting July 19, 2010 FDA ConsiderationsElizabeth Mansfield, PhDOIVDPublic meetingJuly 19, 2010
2 Why are we here?New era of molecular diagnostics and personalized medicineBroad agreement that diagnostics are the linchpin of personalized carePublic needs assurances that diagnostics are sound and reliable
3 Risks FDA Mission Benefits Getting safe and effective devices to market as quickly as possible. . .While ensuring that current devices on the market remain safe and effective. .
4 LDTs provide value Motivated to create new tests for unmet needs Smaller volume testsGeographic proximity/rapid TATSpecialty tests requiring specific technical expertise/trainingRapid response to critical need
5 FDA adds value Risk-based oversight Reasonable assurances: Basic controls, independent premarket review, postmarket monitoringReasonable assurances:Predictable performanceUniform and appropriately controlled manufactureDetection/correction of malfunction, failure
6 What’s happening now Re-assessment of bifurcated regulatory strategy LDTs and traditional commercially distributed IVDsToday, logical basis of bifurcation has fadedLDTs have evolved to be more like commercial IVDsUnlevel playing fieldStifle high-quality innovation?Introduce unreasonable risk?Uncontrolled design/manufactureUnsupported claimsUnreported malfunctions, failures
7 Current issues “LDT” status is self-applied No formal regulatory definition of “LDT”Many labs offer tests created by others as LDTsLDT = loophole, in some casesPreliminary information often packaged as medically actionableFormalized control of design is lackingDirect guide to what and how to validateSoftware is often uncontrolledSoftware design and validation principles are critical
8 Considerations Assuring that LDTs are safe and effective… …while facilitating innovationAvoiding duplication with CLIAUtilizing CLIA or deemed inspectorsAvoiding disruption of testing
9 Risk-based Classification How would an undetected false result affect a patient?Serious injury or death, difficult to detect false result, high public health riskIncorrect and harmful clinical management, invasive procedure, failure to follow upCompanion diagnostics, cancer diagnosis, tests that direct or very strongly influence patient management of serious diease, tests for serious/fatal communicable diseasesNon-serious injury, relatively easy to detect false result, adjunctive testDelayed test results, uncertain clinical management, continued testing, psychosocial issuesTests where phenotype is already known, tests where multiple findings used to direct clinical management, tests to monitor already-detected diseaseLittle potential for injury, easy to detect false result, highly adjunctive testUnlikely to directly affect clinical management, knowledge only without change in management, evaluation without directed managementTests that identify one among many defining characteristics of a tissue or cell, tests that have little clinical impact, certain instruments and equipment
10 Our approach FDA regulates tests, not labs FDA authority can address oversight, to the benefit of labs and consumersLDT problems not applicable across the board, but FDA oversight brings value as a uniform systemRisk-based framework appropriate for all manufacturers adds value
11 Elements that may be helpful Resource management: revisit of currently regulated tests to assess potential for downclassificationRisk-based phase in over time to allow for predictability, planningList of who offers whatCoordinate with NIH’s Genetic Test Registry?Expanded registration and listing?Implement modifications to current oversight structure where appropriate
12 How will FDA manage this? Plan for some re-assessment across the boardGoal to focus on risk, will adjust oversight if neededWe will use and build our resources according to needPhase-in?Downclassification?Pilots for 3rd party accreditation?ReviewInspection
13 How will stakeholders get information? Understood that lots of outreach and education may be neededGuidanceIVD ForumPreIDE programInformational meetingsAdvisory panelsDirect questions to FDA staff
14 Framework To be determined—questions to be addressed Who is offering whatAppropriate risk stratificationAdvisory panels?Which tests/labs (if any) can remain under enforcement discretionPhase-in timelines: review, QSCosts to labsInspection needsNo intention to disrupt testing
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