APPENDIX B: Comparison of Abbreviated
and Full IDE Requirements
Item Abbreviated Full
812.5
812.5(a)
812.5(a)
Labeling requirements
“Caution: Investigational Device” statement................................. x.............x
Contradictions, hazards, adverse effects, interfering
substances or devices, warnings and precautions.......................... x.............x
812.7
Prohibition of promotion............................................................. x.............x
812.20
IDE Application submitted to FDA...........................................................x
812.20(b)(2) Report of Prior Investigations...................................................................x
812.20(b)(2) Summary of Investigational Plan..............................................................x
812.20(b)(3) Description of manufacturing...................................................................x
812.20(b)(4) Example Investigator Agreements, names & address of investigators.....x
812.20(b)(5)
Certification that investigators will follow agreement..............................x
812.20(b)(6) Name, address and chairperson of each reviewing IRB...........................x
812.20(b)(7) Name and address of investigational institutions......................................x
812.20(b)(8) Cost, if device is sold, and why sale does not constitute
commercialization of device.....................................................................x
812.20(b)(9) Environmental assessment of exclusion...................................................x
812.25
Investigational Plan
812.25(a) Purpose......................................................................................................x
812.25(b) Protocol.....................................................................................................x
812.25(c) Risk Analysis............................................................................................x
812.25(d) Description of device................................................................................x
812.25(e) Monitoring procedures..............................................................................x
812.25(f) Labeling....................................................................................................x
812.25(g) Consent materials......................................................................................x
812.25(h) IRB information........................................................................................x
812.25(i) Other institutions.......................................................................................x
812.25(j) Additional records & reports.....................................................................x
812.27
Report of Prior Investigations
812.27(a) General......................................................................................................x
812.27(b)(1) Bibliography.............................................................................................x
812.27(b)(1) Adverse information, published and unpublished.....................................x
812.27(b)(1)
Copies of significant publications.............................................................x
812.27(b)(2) Summary of unpublished information......................................................x
812.27(b)(3) Nonclinical laboratory studies and statement of GLP compliance...........x
812.40
Responsibilities of Sponsors
812.40
Select qualified investigators....................................................................x
812.40 Provide investigators with needed information to conduct study.............x
812.40 Ensure IRB approval obtained..................................................................x
812.40 Inform FDA and IRB of new information................................................x
812.42 Ensure IDE approval by FDA obtained....................................................x
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Citation APPENDIX B
Citation Item Abbreviated Full
812.42 Await IRB and FDS approval....................................................................x
812.43
Selecting Investigators and Monitors
812.43(a)
Select qualified investigators....................................................................x
812.43(b) Ship device only to investigators..............................................................x
812.43(c) Obtain investigator agreement..................................................................x
812.43(c)(5)
Obtain investigator financial information
(Financial Disclosure guideline, Q12)................................... x.............x
812.43(d) Select monitors..........................................................................................x
812.46
Monitoring Investigations
812.46(a) Secure investigator compliance................................................. x.............x
812.46(b) Terminate study if unanticipated adverse effects
present unreasonable risk....................................................... x.............x
812.46(c) Resume with IRB or IRB/FDA approval................................... x.............x
812.60
IRB compliance with Part 56 [See 812.2(b)(ii)]
812.60 IRB review and approval........................................................... x.............x
812.64 IRB continuing review............................................................... x.............x
812.66
Notify investigator and FDA if IRB finds device
to be significant risk............................................................... x
812.100
Responsibilities of investigators
812.100 Follow signed agreement, investigational plan,
and FDA regulations.............................................................................x
812.100 Obtain informed consent [See 812.2(b)(iii)].............................. x.............x
812.110(a) Await IRB and FDA approval...................................................................x
812.110(b) Comply with signed agreement, investigational
plan and FDA regulations.....................................................................x
812.110(c) Supervise device use.................................................................................x
812.110(d)
Disclose financial information................................................... x.............x
812.110(e) Return or dispose of remaining devices....................................................x
812.140(a)
Investigator records
812.140(a)(1) Correspondence.........................................................................................x
812.140(a)(2) Receipt, use or disposition of device........................................................x
812.140(a)(3) Case history & device exposure................................................................x
812.140(a)(3)(i) Signed and dated informed consent....................................... x.............x
812.140(a)(3)(ii) Relevant observations...........................................................................x
812.140(a)(3)(iii) Record of device exposure....................................................................x
812.140(a)(4) Protocol and deviations.............................................................................x
812.140(a)(5) Other FDA required records......................................................................x
812.140(b)
Sponsor Records
812.140(b)(1) Correspondence.........................................................................................x
812.140(b)(2) Shipment & disposition of device.............................................................x
812.140(b)(3) Investigator Agreement.............................................................................x
812.140(b)(3) Financial disclosure................................................................... x.............x
812.140(b)(4)(i) Name and use of device......................................................... x
812.140(b)(4)(ii) Explanation of why not significant risk................................. x
812.140(b)(4)(iii) Name & address of each investigator.................................... x
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Citation Item Abbreviated Full
812.150(a)
Investigator Reports
812.150(a)(1) Unanticipated adverse effects.................................................... x.............x
812.150(a)(2) Withdrawal of IRB approval...................................................... x.............x
812.150(a)(3) Progress reports.........................................................................................x
812.150(a)(4) Deviations from protocol..........................................................................x
812.150(a)(5) Informed consent omission........................................................ x.............x
812.150(a)(6) Final report................................................................................................x
812.150(a)(7) Other.......................................................................................... x.............x
812.150(b)
Sponsor Reports
812.150(b)(1) Unanticipated adverse effects.................................................... x.............x
812.150(b)(2) Withdrawal of IRB approval...................................................... x.............x
812.150(b)(3) Withdrawal of FDA approval..................................................... x.............x
812.150(b)(4) Current investigator list.............................................................................x
812.150(b)(5) Progress reports.......................................................................... x.............x
812.150(b)(6) Recall and device disposition..................................................... x.............x
812.150(b)(7) Final report................................................................................. x.............x
812.150(b)(8) Omission of informed consent report........................................ x.............x
812.150(b)(9)
Significant risk determination report......................................... x.............x
812.150(b)(10) Other FDA or IRB required reports........................................... x.............x
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812.140(b)(4)(iv) Name & address of IRBs....................................................... x
812.140(b)(4)(v) Statement regarding GMP compliance.................................. x
812.140(b)(5) Adverse device effects............................................................... x
812.140(d) Two-year record retention.........................................................................x