IDE试验用器械的豁免.ppt

Investigational Device ExemptionsUS FDA Device Clinical trial Approval,2,Overview,Investigational Device Exemptions(IDE)Regulation 21 CFR 812Applies to all clinical investigations of devices to determine safety and effectivenessFDA oversight of conduct of study,use of device,protection of human subjectsFDA review depends upon determination of Significant Risk(SR)or Nonsignificant Risk(NSR)DeviceDetermination made by sponsor,then IRB;FDA oversight,3,What is an IDE?,IDE permits clinical evaluation of an investigational device(21 CFR Part 812)Investigational devices have not been cleared for marketing,are the object of an investigationAlso includes legally marketed devices with specific modifications or new intended usesClinical evaluation provides safety and effectiveness data to support approval and/or marketing clearanceClinical studies most often conducted in support of PMAsOnly a small number of 510(k)s require clinical data,4,Purpose of IDE Regulations812.1(a),To encourage,to the extent consistent with the protection of public health and safety and with ethical standards,the discovery and development of useful devices intended for human useTo maintain optimum freedom for scientific investigators in their pursuit of this purpose,5,Significant Risk Devices,Definition 21 CFR 812.3(m)Potential for serious risk to subjects health,safety or welfare(life threatening,impair body function/structure,necessitate medical/surgical intervention)ImplantUsed to support or sustain human lifeSubstantially important in diagnosing,curing or mitigating diseaseFull IDE required with FDA and Institutional Review Board(IRB)approvalExamples:implanted catheters,epidural/spinal needles,tracheal tubes,infusion pumps,6,Nonsignificant Risk Devices,No significant risk to subjectAbbreviated IDE requirementsNo FDA approval or review of studyIRB approval:study proposal,why NSR,previous studies,informed consentMonitoring,records and reports requiredExamples:general urological catheters,oximeters,nasal stents,anesthetic gas masks,7,Institutional Review Boards,IRB must comply with regulations outlined in 21 CFR Parts 56 and 812In making approval decisions,same criteria for approval of any research involving an FDA-regulated product should be usedRisks and benefits of an investigational device vs.alternative devices or procedures should be consideredApproval decisions differ from determination of significant risk,which is solely based upon the significance of harm that may result from use of the device,8,IDE-Exempted Investigations 21 CFR 812.2(c),Preamendment devices Substantially equivalent devicesDiagnostic devicesNoninvasiveDoes not require invasive sampling that presents significant riskDoes not introduce energy into subjectIs not used for diagnosis without confirmationConsumer preference testing,9,IDE Application21 CFR 812.20,Report of prior investigations-21 CFR 812.27Investigational plan-21 CFR 812.25Description of methods/controls/facilities for manufacturing,processing,packing and storage of deviceSample PI agreementIRB chairperson contact informationLabeling Informed consent forms and materials,10,FDA Actions on IDE Applications21 CFR 12.30,Sponsor may start investigation 30 days after FDA receives application(unless FDA notifies otherwise)or upon receipt of FDA order of IDE approvalApproval of an IDE signifies that:IRB(and in cases of significant risk devices,FDA)has reviewed and approved the study application;Investigational devices may be lawfully shipped for the purposes of clinical evaluation of the device,without complying with other requirements of the FFDC;andAll requirements under 21 CFR Part 812 have been met.,11,FDA Actions on IDE Applications21 CFR 812.30,Grounds for disapproval:Failure to comply with regulatory requirementsFailure to respond to FDA request for additional informationRisk to subjects outweighs benefits;investigation scientifically unsound;there is reason to believe device is ineffectiveInformed consent inadequateInadequacy of methods,facilities or controls for manufacture,processing,packing or storage of deviceInadequate monitoring and review of investigation,12,Supplemental Applications21 CFR 812.35,Prior approval required for changes in investigational plan except:Changes effected for emergency useTo protect the life or physical well-being of a subject in an emergencyReported within 5 working daysChanges effected with notice to FDA within 5 daysDevelopmental changesChanges to clinical protocolChanges submitted in the annual reportCertain minor changesIRB approval of new facilities,13,Sponsor Responsibilities,FDA&IRB Approval(only IRB for NSR devices)Selection of investigatorsControl of deviceInvestigator agreementsInvestigator CV,experience and qualificationsFollow investigational plan,supervise testing,ensure informed consentFinancial disclosureSelection of monitors/monitor investigationEnsure compliance with investigational planEvaluation of unanticipated adverse device effects,14,Investigators,Responsibilities(812.100-.110):Determining interest of potential subjectsConduct investigation in accordance with approved investigational planSupervise device useFinancial disclosureDisposal of devicesDisqualification(812.119)Deliberately failed to comply with regulationsRepeatedly or deliberately submitted false information to sponsor or in required reports,15,Financial Disclosure,Disclosure of investigators required for:Compensation where value of compensation could be affected by outcome of investigationProprietary interest in tested productEquity interest in sponsor of covered studyEquity interest in a publicly held company that exceeds$50,000Significant payments of other typesCumulative monetary value$25,000;orMade by sponsor to investigator or investigators institution exclusive of the costs of the clinical study or other clinical studies,16,Investigator Records 21 CFR 812.140(a),CorrespondenceSubject recordsCase histories and medical recordsInformed consentRelevant observations including adverse device effectsRecord of exposure to deviceProtocol and supporting documentationOther records required by FDA regulations,17,Sponsor Records 21 CFR 812.140(b),SR DevicesCorrespondenceRecords of shipment and dispositionSigned investigator agreementsRecords for adverse device effectsNSR DevicesName/intended use of deviceWhy device is NSRInvestigator and IRB contact informationGMP informationRecords for adverse device effects,18,Investigator Reports 21 CFR 812.150(a),Unanticipated adverse device effectsWithdrawal of IRB approvalProgress reportsDeviations from investigational planUse without informed consentFinal report,19,Sponsor Reports 21 CFR 812.150(b),Unanticipated adverse device effectsWithdrawal of IRB/FDA approvalCurrent investigator listProgress reportsRecall and device dispositionUse without informed consentFinal reportSignificant risk device determination from IRB,20,FDA Inspectional Authority,Any establishment where devices are heldRecords inspection-all records relating to an investigationRecords identifying subjects-verification of informed consent,complete reports,21,Investigational Devices:Prohibitions,Cannot promote on test marketCannot commercialize by charging more than necessary to recover costs21 CFR 812.20(b)(8):If device is to be sold,must provide the amount charged in IDE application and explain why sale does not constitute commercialization of the deviceCannot unduly prolong investigationCannot represent as safe and effective,22,Warning Letters,23,Warning Letters,