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FDA Tutorial on Cardiovascular Investigational Device Exemptions (IDE) for NIH and Academic Investigatorsdash line

The IDE process (content and organization) with emphasis on preclinical engineering and animal test requirements for feasibility studies.


Target Audience

NIH and Academic Investigators, Device Engineers, Clinical Research Coordinators and Regulators, Grant Officials, Animal Investigators, Fellows, Students

Workshop details

Date: Thursday, June 24, 2010, 9:00am -5:00pm

Location: NIH Campus, National Library of Medicine Lister Hill Auditorium
http://www.nlm.nih.gov/psd/ref/guide/rrdirect.html
Webcast live to interested outside investigators, stored for later off-line viewing
Number of on-site participants expected: 60


Agenda

Complete file and slideset: FDA-NHLBI-Tutorial 2010.zip (zip file logo 5 MB)

9:00 am Welcome – Robert J. Lederman, National Heart Lung and Blood Institute

9:00 am – 9:15 am I. Definitions / Background / Format of workshop - Tina Morrison :
Product Life Cycle of an Investigational Device Exemption (powerpoint logo 20 KB)

9:15 am – 9:4 5am II. Contents of the IDE application - Lynn Henley (30 min):
Contents of the IDE Application (powerpoint logo 182 KB)

9:45 am – 10:45 am III. Report of prior investigations: all prior clinical, bench and animal testing

    A. Clinical – Tara Ryan:
        Reports of Prior Investigations Clinical Testing (powerpoint logo 81 KB)

    B. Bench Testing / Risk Analysis / Device Description –
        Tina Morrison:
        Report of Prior Investigation: In Vitro Testing (powerpoint logo 2 MB)

10:45 am - 11:00 am BREAK

11:00 am – 12:00 pm III. Report of prior investigations: all prior clinical, bench and animal testing

     A. Animal Studies – Tory Hampshire:
Preclinical Animal Studies for Cardiovascular Devices (powerpoint logo 84 KB)
Hampshire-handout (powerpoint logo 60 KB)

12:00 pm – 1:00 pm LUNCH

1:00 pm – 1:30 pm IV. Investigation Plan - Tara Ryan:
Investigational Plan (powerpoint logo 107 KB)

1:30 pm – 1:40 pm V. Design Controls / GMPs - Michelle Noonan-Smith:
Design controls (powerpoint logo 31 KB)

1:40 pm – 2:00 pm BREAK

2:00 pm – 2:30 pm VI. Bioresearch Monitoring Inspections: Protection of Human Subjects - Jonathan Helfgott:
CDRH’s Bioresearch Monitoring (BIMO) Program (powerpoint logo 159 KB)

Data Integrity & Computerized Systems used in Device Clinical Research - Jonathan Helfgott:
Computer systems (powerpoint logo 3.44 MB)

2:30 pm – 2:45 pm VII. HUD’s & HDE Application - Eric Chen:
HUDs and HDEs (powerpoint logo 192 KB)

2:45 pm – 3:45 pm Q&A Session – Panel of Speakers

3:45 pm – 4:00 pm VIII. Closing Remarks - Tina Morrison:
Closing Remarks (powerpoint logo 226 KB)



Speakers

Fernando Aguel - Biomedical Engineer, DCD/ODE
Eric Chen - Director, Humanitarian Use Devices Designation Program, OOPD
Victoria Hampshire, VMD - Director of Device Review, DCD/ODE
Jonathan Helfgott - Consumer Safety Officer, DBM/OC
Lynn Henley, MS, MBA - Staff, IDE/ODE and HDE/OOPD
Tina Morrison, PhD - Medical Device Fellow, DCD/ODE
Michelle Noonan-Smith - Senior Regulatory Operations Officer, OC
Tara Ryan, MD - Medical Office, DCD/ODE

Acronyms:
CDRH - Center for Devices and Radiological Health
OC - Office of Compliance
ODE - Office of Device Evaluation
OOPD - Office of Orphan Products Development
DBM - Division of Bioresearch Monitoring
DCD - Division of Cardiovascular Devices

HDE - Humanitarian Device Exemption, Program
HUD - Humanitarian Use Device, Program
IDE - Investigational Device Exemption, Program


For More Information

Zambia Davis, Staff Assistant, NHLBI Translational Medicine Branch
+1-301-451-8014      mcleodz@mail.nih.gov

Annette Stine, RN, Research Coordinator
+1-301-402-5558      stinea@nhlbi.nih.gov


Live Webcast and Video Archive

http://videocast.nih.gov/summary.asp?live=9365


References:

Guidance documents on medical devices and radiation emitting products:
Medical Devices and Radiation-Emitting Productsexternal link

  1. How to prepare an IDE:
    Device Advice: Investigational Device Exemption (IDE)external link
  2. And sublink for IDE content:
    IDE Applicationexternal link
  3. Design Control Guidance for Medical Device Manufacturers.
    Inspection of Medical Device Manufacturersexternal link
  4. Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1).
    Submit a 510(k)external link
  5. Guidance for Industry and FDA Staff - Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems.
    Guidance for Industry and FDA Staffexternal link
  6. Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications.
    Heart Valvesexternal link
  7. Draft Guidance for Industry and FDA Staff: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions.
    Premarket Notification [510(k)] Submissionsexternal link
  8. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
    Medical Devicesexternal link
  9. General Principles of Software Validation; Final Guidance for Industry and FDA Staff.
    Software Validationexternal link
  10. Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.
    Percutaneous Transluminal Coronary Angioplastyexternal link
  11. Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff.
    Annuloplasty Rings 510(k)external link
  12. Guidance on premarket notification (510K) submission for short and long-term vascular catheters.
    Premarket notification (510K)external link
  13. Draft Guidance for Industry and FDA Staff - Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation.
    Surgical Ablation Devicesexternal link
  14. Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.
    Recombinant DNA Technologyexternal link
  15. A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems.
    Medical Device Interactionsexternal link

Recognized Consensus Standards:
Search Recognized Consensus Standardsexternal link







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