1	FDA/CDRH Office of In Vitro Diagnostic Devices The Pre-IDE Process Sousan S. Altaie, Ph.D. Scientific Policy Advisor
2	The #1 factor impacting review timeliness is Quality of the Submission
3	An Overview Introduction Pre-IDE Process Protocol proposal by sponsor Review by FDA review team Meeting with sponsor Written feed back to sponsor Summary Question and answer period
4	Introduction What is a Pre-IDE? A misnomer A free consultative service by the review staff at the FDA A non binding agreement between FDA & sponsor Results in a well prepared submission Results in a shortened review time Results in saving research $$$
5	Pre-IDE Process
6	Protocol proposal (1) Introduction A clearly stated intended use Test principles Device description
7	Intended Use Statement Should address the followings: Qualitative or Quantitative Testing matrix Intended Population Adult /Children/Age limitations Asymptomatic--Screening Symptomatic--Diagnosis Already diagnosed--Monitoring In conjunction with other diagnostics or stand alone test
8	Protocol proposal (2) Objectives of the clinical Study To substantiate the proposed intended use To establish the assay performance characteristics
9	Protocol proposal (3) Study Design--points to consider A controlled comparative study to establish clinical performance of device compared to an established endpoint or surrogate Clearly show how endpoints are defined Patient samples should have inclusion and exclusion criteria
10	Study Design (continued) The number of patients/samples to be enrolled/used should be determined on sound statistical parameters Provide protocols for patient/sample information collection and documentation How and by whom Consider having > 3 clinical sites provide contact information for all the PIs
11	Protocol proposal (4) Laboratory testing Procedures Clinical labs performing the testing during clinical trial Should follow the procedure in the proposed product insert for both the comparetor and the test device Specimen type should be defined specimen collection, transport, process, and storage Should be defined Quality control for the assay should be defined frequency and trouble shooting
12	Protocol proposal (5) Study results How results are reported to sponsor How results are analyzed Describe statistical tests Describe how discrepant results are handled Definition of true positive, true negative, equivocal, and inconclusive results for the purpose of establishing performance of the device
13	Protocol proposal (6) Regulatory & Administrative information Study’s start and finish dates Obligations of the PI and sponsor IRB & informed consent (non-US, Helsinki Accord) Study site monitoring SOPes for protocol deviation & change
14	Protocol review by FDA Review Team Division team leader Division review staff Internal and external Consultant CDER, CBER, CDRH, CVM, CFSAN, CDC, NIH... Internal FDA discussions Creation of consensus
15	Meeting with sponsor Face to Face Teleconference Videoconference
16	Written feed back E-mail Fax Mail
17	Summary The pre-IDE is the current agency’s thinking extremely flexible framework for product development does not bind the FDA or the sponsor A streamlined method in which the FDA and the sponsor can agree on criteria and data necessary to insure safety and efficacy of device prior to start of preclinical and clinical trials → $$$$
18	Pre-IDEs in 2005 OIVD reviewed 141 original pre-IDEs. OIVD Made 150 decisions on original pre-IDEs. 62% of all original pre-IDE decisions were issued within 60 days The average review time was 67 days OIVD received 76 pre-IDE supplements OIVD made 72 decisions on supplements 60% reviewed within the 60-days The average review time was 59 days.
19	Average Pre-IDE Review Time for Decision Cohort
20	Average Pre-IDE Review Time for Decision Cohort
21	Real-life Example Same device type Same branch Same reviewer Same timeframe different quality
22	Another Example Same as previous slide Quality Submission Right Studies Sponsor improvement
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