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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

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Presentation on theme: "Investigational Device Exemptions 21 CFR Part 812 A Review for OCRA US RAC Study Group September 2005 Ginger Clasby, MS Promedica International"— Presentation transcript:

1 Investigational Device Exemptions 21 CFR Part 812 A Review for OCRA US RAC Study Group September 2005 Ginger Clasby, MS Promedica International x 25

2 IDE About 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

3 When IDE Application Not Required Clinical 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

4 Defining Device Types Significant 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

5 Defining Device Types Significant or Non-significant Risk? How to decide? Sponsor makes initial determination; IRB makes final call

6 Regulatory Differences Significant 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

7 IDE Application Contents Administrative 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

8 IDE Application Contents An 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

9 IDE Application Contents An 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

10 IDE Contents Report 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)

11 IDE Contents Investigational Plan Study purpose Proposed protocol Risk analysis Device description Monitoring procedures Labeling Consent materials

12 IDE Contents Investigational Plan IRB info Info on core labs, reading centers, etc. Addl records & reports

13 IDE Review/Approval FDAs 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 addl info – Subject risks outweigh benefits – Unreasonable to proceed due to inadequacy of investigational plan, manufacturing or monitoring

14 Prohibited Practices Under IDE Sponsors & 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

15 IDE Supplements Necessary 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

16 Treatment IDE Appropriate 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

17 Sponsor Responsibilities Subpart 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

18 Sponsor Responsibilities Subpart 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

19 Sponsor Responsibilities Subpart 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

20 Sponsor Responsibilities Subpart 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

21 Sponsor Responsibilities Subpart 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

22 IRB Responsibilities Subpart 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

23 IRB Responsibilities Subpart G – Records & Reports Records maintained in accordance with 21 CFR 56

24 IRB Responsibilities Subpart G – Inspections Must permit access by FDA employees to inspect & copy study-related records

25 Investigator Responsibilities Subpart 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

26 Investigator Responsibilities Subpart 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

27 Investigator Responsibilities Subpart 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

28 Investigator Responsibilities Subpart 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

29 IDE Regulation Reference Documents & Links (www.fda.gov/cdrh)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)

30 IDE Regulation Reference Documents & Links (www.fda.gov/cdrh)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


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