Presentation on theme: "Strengthening the Medical Device Clinical Trial Enterprise"— Presentation transcript:
1Strengthening the Medical Device Clinical Trial Enterprise Owen Faris, Ph.D.Clinical Trials Director (acting)CDRH/FDA
2Outline Clinical trial enterprise priority Recent performance Early feasibility study focusFDASIAFuture directions
3The IDE ChallengeThe IDE review process is an important part to protecting subjects in investigational device studiesWe also recognize, the sooner an IDE is approved, the sooner a potentially important technology can be available to US patientsThe IDE process has at times led to avoidable bottlenecks in the processWe can and should look for ways to improve the process of FDA’s decision making for IDEs
4CDRH 2014 Strategic Priority: Goal: Improve the efficiency, consistency, and predictability of the IDE process to reduce the time and number of cycles needed to reach appropriate IDE full approval for medical devices, in general, and for devices of public health importance, in particular.Goal: Increase the number of early feasibility/first-in-human IDE studies submitted to FDA and conducted in the U.S.
5What is CDRH doing to get there ? Established Clinical Trials Program and Clinical Trials Director (CTD)Established SOP for CTD involvement and review of certain IDE decisions. Focus on:Ensuring CDRH is “in the right place”Ensuring flexibility is applied where appropriateIncreased communication with sponsorsEstablished Early Feasibility Study (EFS) coordinators within Clinical Trials Program
630 Day IDE Review Round 1 DSAP IDE SOP Provisions10 DaysFDA offers a teleconference to clarify reasons for decision30 Day IDE Review Round 1 DSAP
730 Day IDE Review Round 1 DSAP IDE SOP ProvisionsFDA offers a teleconference to clarify reasons for decision30 Day IDE Review Round 1 DSAP10 DaysCTD included in 10-day t-conCTD and team meet internallyRound 2 DSAP or APCN
830 Day IDE Review Round 1 DSAP IDE SOP ProvisionsFDA offers a teleconference to clarify reasons for decision30 Day IDE Review Round 1 DSAP10 DaysCTD included in 10-day t-conCTD and team meet internallyRound 2 DSAP or APCNReview team notifies CTD that response is under reviewConsultants provide review in 14 daysCTD notified 5 days prior to decision letterRound 3+ DSAP or APCN
9Clinical Trials Program Outcomes Helps ensure consistency in decision-makingFacilitates sharing of best practices across divisionsEncourages higher levels of interactionHelps prepare sponsor to respond10-day meeting
10FY2014 GoalsBy September 30, 2014, compared to FY13 performance, CDRH seeks to:Reduce the number of IDEs requiring more than two cycles to an appropriate full approval decision by 25%Reduce the overall median time to appropriate full IDE approval by 25%
12Recent Performance* This is a conservative estimate of the current FY14 performance since it assumes that all IDEs that have not yet completed two cycles of review will not be approved within two cycles
13FY2015 GoalsBy June 30, 2015, compared to FY13 performance, CDRH seeks to:Reduce the number of IDEs requiring more than two cycles to an appropriate full approval decision by 50%Reduce the overall median time to full appropriate IDE approval to 30 days.Increase the number of early feasibility/first-in-human IDE studies submitted to each premarket Division
14Early Feasibility Study (EFS) Program Intent - To facilitate US EFS under the IDE regulationsScope - Elements that define an early feasibility study:Small number of subjectsDevice that may be early in development, typically before the device design has been finalizedDoes not necessarily involve the first clinical use of a device
15Purpose of Early Feasibility Studies safetywhether the device performs its intended purposetherapeutic parametersdevice failurespatient characteristics that may impact device performancehuman factorsoperator technique challengesOBTAIN INSIGHTSWhat sponsors may be looking to learn from EFS
16EFS GuidanceKey Guidance Principle - Approval of an early feasibility study IDE may be based on less nonclinical data than would be needed to support the initiation of a larger clinical study of a more final device designGuidance Provisions - A regulatory toolkit that enables sponsors and regulators to think in new ways about device developmentJustifying the appropriate evidence needed to move from bench to clinical studyAllowing timely device and clinical protocol modifications
17The Right Testing at the Right Time Comprehensive testing during early phases of device development may add cost without significant returnIt may be acceptable to defer some nonclinical testing until the device design has been finalizedAn early feasibility study incorporates enhanced risk mitigation strategies and patient protection measures as compared to a pivotal study
18EFS ProcessSponsors contact EFS coordinators and interact informally to:Discuss the EFS guidance policies and principlesHelp with understanding the device evaluation strategy (DES) concept and developing the DES tablePrepare for initial interactions with the review teamSubmit the initial Pre-SubReach agreement on the information needed in the Report of Prior Investigations to support study initiationSupplement Pre-Sub as neededSubmit the original IDE and continue interacting with CDRH throughout the conduct of the EFS
19FDASIA Section 601 Amends Section 520(g)(4)(C) of the FD&C Act FDA shall not disapprove an IDE because:the investigation may not support a substantial equivalence or de novo classification determination or approval of a device;the investigation may not meet a requirement, including a data requirement, relating to the approval or clearance of a device; oran additional or different investigation may be necessary to support clearance or approval of the device.
20FDASIA Section 601This means that an IDE cannot be disapproved on the basis of FDA’s belief that the study design is inadequate to support a future PMA, 510(k), HDE, or de novo classification.The standards for market approval (PMA/HDE) or clearance (510(k)) have not changed.
21FDASIA Section 601FDA issued final Guidance which explained FDA’s decision making process for IDEsConcerns related to study design that are not related to protecting study subjects are not basis for disapproval.Study design considerations communicated as attachment to decision letter
22Clinical Trials Program: Future Plans Continued monitoring of performance for IDEs in general and EFS IDEsDraft Benefit-Risk Guidance for IDEsThorough assessment of the major reasons for IDE disapprovalsSubmission quality improvementsDevelopment of clinical trials training program for review staff
23Possible Topics for Discussion Early Feasibility StudiesHow can FDA get industry stakeholders to partner in this effort?Submission qualityMany IDEs are missing basic critical infoOthers fail to tell the sponsor’s storyWhat’s the solution?Pre-submissionsThe value and the challenges