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

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 ( 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 ( 20 KB)
9:15 am – 9:4 5am	II. Contents of the IDE application - Lynn Henley (30 min): Contents of the IDE Application ( 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 ( 81 KB) B. Bench Testing / Risk Analysis / Device Description – Tina Morrison: Report of Prior Investigation:In Vitro Testing ( 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 ( 84 KB) Hampshire-handout ( 60 KB)
12:00 pm – 1:00 pm	LUNCH
1:00 pm – 1:30 pm	IV. Investigation Plan - Tara Ryan: Investigational Plan ( 107 KB)
1:30 pm – 1:40 pm	V. Design Controls / GMPs - Michelle Noonan-Smith: Design controls ( 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 ( 159 KB) Data Integrity & Computerized Systems used in Device Clinical Research - Jonathan Helfgott: Computer systems ( 3.44 MB)
2:30 pm – 2:45 pm	VII. HUD’s & HDE Application - Eric Chen: HUDs and HDEs ( 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 ( 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 Products external link

How to prepare an IDE:
Device Advice: Investigational Device Exemption (IDE)
And sublink for IDE content:
IDE Application
Design Control Guidance for Medical Device Manufacturers.
Inspection of Medical Device Manufacturers
Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1).
Submit a 510(k)
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 Staff
Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications.
Heart Valves
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)] Submissions
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Medical Devices
General Principles of Software Validation; Final Guidance for Industry and FDA Staff.
Software Validation
Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.
Percutaneous Transluminal Coronary Angioplasty
Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff.
Annuloplasty Rings 510(k)
Guidance on premarket notification (510K) submission for short and long-term vascular catheters.
Premarket notification (510K)
Draft Guidance for Industry and FDA Staff - Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation.
Surgical Ablation Devices
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.
Recombinant DNA Technology
A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems.
Medical Device Interactions

Recognized Consensus Standards:
Search Recognized Consensus Standards external link

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