for 510k Submissions Consultants and RA Experts have used these for years but they werent called presub meetings Agenda What is a presub meeting Is a presub meeting required for 510k submissions ID: 1042411
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1. FDA Pre-Submission Meetingsfor 510(k) SubmissionsConsultants and RA Experts have used these for years, but they weren’t called “pre-sub” meetings.
2. AgendaWhat is a pre-sub meeting?Is a pre-sub meeting required for 510(k) submissions?When to request a pre-sub meetingIntegrating pre-sub into design planPreparing for a pre-sub meetingFormat and content of a pre-sub requestIn Person vs. TeleconferenceWhat you should never ask during a pre-subWhat if you disagree with the FDA?
3. What is a pre-sub meeting?A meeting with the FDA in order to ask questions specific to a planned regulatory submission:510(k) ApplicationDe Novo ApplicationInvestigation Device Exemption (IDE)Pre-Market Approval (PMA)Usually a one-time meeting rather than iterative
4. GuidanceThe Pre-Submission Program and Meetings with FDA StaffDraft guidance issued July 13, 2012Final guidance issued February 18, 2014Supersedes Pre-IDE Program: Issues and Answers - Blue Book Memo D99-1, dated March 25, 1999http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf
5. Not Just for Pre-IDEPre-sub meetings are not used just for preparing an Investigational Device Exemption (IDE) SubmissionOther Uses:De Novo SubmissionsReview of Draft Special ControlsPre-Subs tracked as “Q Submissions”Meetings Upon Request – 75-90 Days from the date of Submissionhttp://www.fda.gov/downloads/training/cdrhlearn/ucm387291.pdf
6. Is a pre-sub meeting required?
7. Submission Logistics1 eCopy (http://bit.ly/FDA-eCopy) & 1 hardcopyCover letter ContentIdentify submission as “Pre-sub Meeting Request”Sponsor Contact InfoDevice NameInformation specific to Q-Sub type (Should be “Pre-Submission”)Address:U.S. Food and Drug AdministrationCenter for Devices and Radiological HealthDocument Control Center –WO66-G60910903 New Hampshire AvenueSilver Spring, MD 20993-0002DCC = Document Control CenterTLA = Three Letter Acronym
8. When to have a pre-sub?Earliest TimeWhen you have reviewed and approved your design inputs.Latest TimeAt design freeze.Before a long-term clinical study.
9. Integrating Pre-Sub w/Design & Risk PlansDHFBeginsProductLaunch510(k)Design TransferConceptPhaseFeasibilityPhaseDevelopmentPhasePilotPhaseReleasePhaseHazardIdentificationRisk ControlOption AnalysisRiskAssessmentRisk ControlEffectivenessVerificationRiskManagementPlanRisk / BenefitAnalysisRisk ManagementReportDR
10. Pre-Sub TimelineRTA Process (0-14 days)Does request qualify as a pre-sub?Is submission sufficiently complete?Contact Submitter to schedule date/time of meeting (15-21 days)Submit agenda for meetingallot last 10 minutes to summarizing discussion and action itemsFDA Provides preliminary feedback 3-days prior to the pre-sub meeting (sometimes meeting is cancelled)FDA Provides feedback (75-90 days)Sponsor provides draft minutes to DCC (15 days)FDA reviews/edits draft meeting minutes (30 days)May present courtesy copy to reviewer of final meeting minutes.
11. Basics of a Pre-subProvide several options for dates to remain flexibleAgenda should limit presentation of information to approximately 1/3 the allotted time for meetingClear and concise background informationSpecific questions for FDAIf for a clinical study (NSR, IDE or OUS), then entire protocol may be submitted
12. General Content of a Pre-subCover letterTable of contentsDevice descriptionProposed Intended/Indications for UsePrevious discussions or submissionsOverview of product developmentSpecific questionsMethod for feedbackin-person meetinga teleconferenceFaxemail
13. 510(k) Content for Pre-SubProposed predicate device(s)Trade name & model number510(k) numberClassification of the predicate deviceComparison of predicate(s) with subject deviceIndications for UseTechnological characteristicsPerformance testingPerformance Testing
14. Proposed Test Plan Detailsobjective or purpose of the testexplanation of the sample size and statistical methodssummary of the test methodology (if you are following a recognized standard, include the name of the standard and year of publication)explanation of study endpointsexplanation of study acceptance criteria
15. Do not include test results & data
16. If requesting in-person or tconthree (3) or more preferred dates and times when you are available to meet using the guidelines in Table 1 above for scheduling;the planned attendees, including each attendee’s position, or title, and affiliation. If you have not yet identified all of your attendees, you should indicate the type of subject matter experts you plan to invite so that we can ensure appropriate FDA experts are in attendance. Please note foreign visitors meeting in an FDA facility require advanced security clearance. See Section IV. B. “Security Screening” below for additional information on how to request security clearance for Foreign Nationals; anda list of any audiovisual equipment you will need, such as conference phone or LCD projector.
17. Pre-Sub QuestionsIs justification of no carcinogenicity testing acceptable?Does FDA agree with “worst-case” rationale?Is software “moderate level of concern”?Is planned approach for human factors acceptable?Are there concerns of predicate selected?
18. IVD-Specific ConsiderationsRequest a pre-sub before conducting clinical, nonclinical, or analytical studies or submitting a marketing application for a new IVD that:Is a multiplex device capable of simultaneously testing a large number of analytesContains a new technologyHas a new intended useIncludes a new analytePresents new clinical questionsPresents complex data/statistical questionsUses a predicate or reference method that is unclear or uncertain
19. Preparing for a Pre-SubDo your homework 1st.Prepare documentation early and submit with Pre-Sub meeting request – including proposed agendaPractice your questions and responses to potential questions by role playingSubmit focused questions in advanceDevelop the agenda based on these questionsBring the right experts to execute your objectivesHave an expert present that can “kick you”.If you are visiting the FDA in-person, be sure to arrive 30 minutes early. FDA will greet you 10 minutes prior.You will need ID for in-person meetings.Have a dedicated scribe to take notes.
20. Clinical Study:Agreement on Study SizeNever ask how many patient subjectsAlways suggest a study design insteadPresent Clinical SynopsisOr a Clinical ProtocolInclude non-clinical dataInclude similar clinical studies with the same device, but a different indicationhttp://medicaldeviceacademy.com/clinical-procedure/ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812
21. De Novo Data Requirements“Generally, isolated case reports, random experience, reports lacking sufficient details to permit scientific evaluation, and unsubstantiated opinions are not regarded as valid scientific evidence to show safety or effectiveness. However, such information may be considered in identifying a device that has questionable safety and effectiveness.”IDE not required or foreign clinical studies and studies of non-significant risk (NSR)
22. De Novo Classification?What makes the device a Class I?What makes the device a Class II?What makes the device Class I or Class II exempt?274 Device Classifications are Class II with 510(k) exemptionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm
23. What not to do for Pre-Sub…Do not request a meeting just to give the FDA infoDo not ask the FDA to help suggest performance bench testing or animal studiesDo not ask the FDA to help design a clinical studyDo not ask questions that can be directed to the reviewerDo not ask for classification decision – 513(g)Do not ask for designation of jurisdiction (RFD)Do not ask for determination on a submissionDo not ask for agreement on clinical data requirementsDo not ask if data is acceptableDo not bother if you already did your testinghttp://medicaldeviceacademy.com/fda-device-classification/
24. Non-Binding FeedbackFDA intends to stand behind our feedback unless:Information in subsequent submission is not consistent with pre-sub (e.g., change in proposed indication for use or device design)Data in the subsequent submission raise important new issues related to safety and effectiveness (e.g., a study is conducted as recommended by FDA, but results raise new safety concerns)Feedback given previously does not adequately address important new issues materially relevant to a determination of safety or effectiveness that have emerged since the time of the pre-sub (e.g., new alternative therapies/diagnostics have emerged since discussion of the clinical protocol making the previously recommended study design unethical)
25. Meeting MinutesA summary—not a transcriptNo responses to FDA feedbackFollow-up requestsSubmit a Q-Sub Supplement insteadSubmit draft meeting minutes to DCCFDA edited version becomes final within 15 days, unless sponsor submits “minutes disagreement amendment”…not a disagreement with feedback, but a disagreement with what was said
26. Disagreement with FDADo not argue, because you don’t have to agree with the agency.Summarize action items at the end and ask for clarification.
27. Risk / Benefit RatioAre there any risks to having a pre-sub meeting?What are the benefits of a pre-sub meeting?
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