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A Review for OCRA US RAC Study Group September 2005 Ginger Clasby, MS Promedica International gclasby@promedica-intl.com 714-799-1617 x 25. Investigational Device Exemptions 21 CFR Part 812. IDE About the Regulation.

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Investigational Device Exemptions 21 CFR Part 812


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investigational device exemptions 21 cfr part 812

A Review for OCRA US RAC Study Group

September 2005

Ginger Clasby, MS

Promedica International

gclasby@promedica-intl.com

714-799-1617 x 25

Investigational Device Exemptions21 CFR Part 812
ide about the regulation
IDEAbout the Regulation
  • Provides procedures for conduct of clinical studies for unapproved devices
  • Exempts products from 510(k) or PMA approval requirements:
    • Registration, listing, interstate distribution
    • Labeling
    • GMPs
  • Applies to most studies to determine device safety & effectiveness
when ide application not required clinical study situations
When IDE Application Not RequiredClinical Study Situations
  • Device legally marketed for indicated use
    • Marketing preference studies
    • Market seeding studies
  • Device is substantially equivalent to pre 1976 commercially distributed device
  • Device is non-significant risk & IRB has approved study
  • Many diagnostic devices
  • Veterinary devices
  • Custom device
defining device types significant or non significant risk
Defining Device TypesSignificant or Non-Significant Risk?
  • Significant Risk: device has potential for serious risk to patient health, safety or welfare
    • Implants
    • Products supporting/sustaining life
    • Products with substantial role in diagnosing, curing mitigating or treating disease (or preventing impairment of human health)
  • Non-Significant Risk: all other devices
defining device types significant or non significant risk5
Defining Device TypesSignificant or Non-significant Risk?

How to decide?

Sponsor makes initial determination; IRB makes final call

regulatory differences significant vs non significant risk
Regulatory DifferencesSignificant vs. Non-significant Risk
  • Significant Risk Devices require FDA (IDE) & IRB approval prior to clinical study initiation
  • Non-Significant Risk Devices require only IRB approval prior to clinical study initiation
    • IDE presumed, unless FDA notified Sponsor that application is required
ide application contents administrative details
IDE Application ContentsAdministrative Details
  • Sponsor responsibility
  • 3 copies of submission required
  • All correspondence related to IDE sent by registered mail or by hand
  • IDE approval required prior to study initiation
ide application contents an overview
IDE Application ContentsAn Overview
  • Sponsor name & address
  • Report of prior investigations & investigational plan
  • Description of methods, facilities, controls used for device manufacture, processing, packaging, storage & use
  • Names of proposed investigators & example of proposed investigator agreements
  • Certification that all investigators will sign agreement prior to study participation
ide application contents an overview9
IDE Application ContentsAn Overview
  • List of name, address & chairperson of each IRB reviewing study
  • If device will be “sold”, amount to be charged and rationale for why sale does not constitute commercialization
  • Environmental exemption/assessment
  • Proposed device labeling
    • “Caution – Investigational Device Limited by Federal (or US) Law to Investigational Use”
  • Copies of all informed consent documents
ide contents report of prior investigations
IDE ContentsReport of Prior Investigations
  • Reports of all prior clinical, animal & lab testing of device – should be adequate to justify proposed study
  • Bibliography of related publications
  • Summary of unpublished info
  • Non-clinical lab studies (in compliance with GLP)
ide contents investigational plan
IDE ContentsInvestigational Plan
  • Study purpose
  • Proposed protocol
  • Risk analysis
  • Device description
  • Monitoring procedures
  • Labeling
  • Consent materials
ide contents investigational plan12
IDE ContentsInvestigational Plan
  • IRB info
  • Info on core labs, reading centers, etc.
  • Add’l records & reports
ide review approval fda s considerations
IDE Review/ApprovalFDA’s Considerations
  • Approval/disapproval decision
  • Rendered in writing
  • Rendered  30 days of FDA receipt
  • Approval may be denied/rescinded if:
    • Sponsor fails to comply with applicable regulations
    • Sponsor is non-responsive to requests for add’l info
    • Subject risks outweigh benefits
    • Unreasonable to proceed due to inadequacy of investigational plan, manufacturing or monitoring
prohibited practices under ide sponsors investigators
Prohibited Practices Under IDESponsors & Investigators
  • Promotion of investigational product
  • Representing device as safe or effective for use in the study
  • Commercializing device by charging more than cost-recovery
  • Unduly prolonging study
    • Enrolling more subjects than necessary
ide supplements necessary when
IDE SupplementsNecessary When:
  • Changes made to investigational plan that may affect:
    • Scientific soundness of study
    • Rights, safety or welfare of study subjects
  • Changes in device design
  • Changes in device manufacturing
  • Addition of study investigators
treatment ide appropriate when
“Treatment” IDEAppropriate When:
  • Device intended to treat or diagnose serious or life-threatening condition
  • No satisfactory alternative available
  • Controlled clinical trials in progress under IDE
    • Or when trials completed & FDA review of request to market is pending
  • Sponsor actively pursuing device marketing approval with FDA
sponsor responsibilities subpart c
Sponsor ResponsibilitiesSubpart C
  • Selection of qualified investigators & maintenance of ongoing communications
  • Appropriate monitoring of study
    • Special emphasis on device-related adverse events
  • Confirmation of IRB review/approval
  • Submission of IDE application to FDA
  • Prompt notification of significant new information to FDA, IRB
sponsor responsibilities subpart g records
Sponsor ResponsibilitiesSubpart G – Records
  • Maintenance of records:
    • Study-related correspondence
    • Device shipment/disposition
    • Signed investigator agreements & financial disclosure info
    • Non-significant risk justification (if applicable)
    • Adverse device effects & complaints
  • Record retention ≥ 2 yr after study completion or date no longer required for PMA application
  • Record custody transferable with notice to FDA
sponsor responsibilities subpart g inspections
Sponsor ResponsibilitiesSubpart G – Inspections
  • Must permit access by FDA employees to inspect facility where devices are held
  • Must permit access by FDA employees to inspect & copy study-related records
sponsor responsibilities subpart g reports
Sponsor ResponsibilitiesSubpart G – Reports
  • Unanticipated adverse device effects – 10 working days
  • Withdrawal of IRB approval – 5 working days
  • Withdrawal of FDA approval – 5 working days
  • Current investigator list – every 6 months
  • Progress reports – at least yearly
  • Device recalls & disposition – 30 working days
sponsor responsibilities subpart g reports21
Sponsor ResponsibilitiesSubpart G – Reports
  • Study completion (significant risk) - 30 working days
  • Final report - 6 months
  • Use of device without written consent – 5 working days
  • Significant risk determination – 5 working days
irb responsibilities subpart d
IRB ResponsibilitiesSubpart D
  • Membership, duties & functions in accordance with 21 CFR 56
  • Review of research
    • Initial review prior to study initiation
    • Significant risk determination, if necessary
    • Continuing review throughout study
irb responsibilities subpart g records reports
IRB ResponsibilitiesSubpart G – Records & Reports
  • Records maintained in accordance with 21 CFR 56
irb responsibilities subpart g inspections
IRB ResponsibilitiesSubpart G – Inspections
  • Must permit access by FDA employees to inspect & copy study-related records
investigator responsibilities subpart e
Investigator ResponsibilitiesSubpart E
  • Compliance with:
    • Investigational plan
    • Investigator agreement(s)
    • Applicable FDA regulations
  • Protection of subject rights & welfare
  • Control of investigational devices
  • Obtaining consent in accordance with 21 CFR part 50

Repeated noncompliance with assigned responsibilities may result in investigator disqualification by FDA

investigator responsibilities subpart g records
Investigator ResponsibilitiesSubpart G – Records
  • Maintenance of records:
    • Study-related correspondence
    • Product receipt, use, or disposition
    • Subject case records
    • Protocol & amendments
  • Record retention ≥ 2 yr after study completion or date no longer required for PMA application
  • Record custody transferable with notice to Sponsor, FDA
investigator responsibilities subpart g inspections
Investigator ResponsibilitiesSubpart G – Inspections
  • Must permit access by FDA employees to inspect facility where devices are held
  • Must permit access by FDA employees to inspect & copy study-related records
  • Must permit access by FDA employees to inspect & copy records identifying subjects, if:
    • Suspicion that adequate consent was not obtained
    • Required investigator reports incomplete, inadequate, false
investigator responsibilities subpart g reports
Investigator ResponsibilitiesSubpart G - Reports
  • Unanticipated adverse device effects – 10 working days
  • Withdrawal of IRB approval – 5 working days
  • Progress reports – at least yearly
  • Deviations from investigational plan – 5 working days
  • Device use without documentation of consent – 5 working days
  • Final report - 3 months
ide regulation reference documents links www fda gov cdrh
IDE RegulationReference Documents & Links (www.fda.gov/cdrh)
  • Guidance on IDE Policies & Procedures (1/1998)
  • Early Collaboration Meetings Under FDA Modernization Act (FDAMA), Final Guidance for Industry & CDRH Staff (2/2001)
  • Guidance on Significant & Non-Significant Risk Device Studies 7/25/86 (D86-1)
  • The Least Burdensome Provisions of FDA Modernization Act of 1997: Concept & Principles; Draft Guidance for FDA & Industry (5/3/2001)
ide regulation reference documents links www fda gov cdrh30
IDE RegulationReference Documents & Links (www.fda.gov/cdrh)
  • FDA Guidance for Financial Disclosure by Clinical Investigators
  • FDA Guidance for IRBs & Clinical Investigators
  • FDA Guidance for Monitoring Clinical Investigations
  • FDA/ORA Compliance Program Guidance for Bioresearch Monitoring of Clinical Investigations
  • FDA CDRH Device Advice