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.
NIH and Academic Investigators, Device Engineers, Clinical Research Coordinators and Regulators, Grant Officials, Animal Investigators, Fellows, Students
Date: Thursday, June 24, 2010, 9:00am -5:00pm
Location: NIH Campus, National Library of Medicine Lister Hill Auditorium
Webcast live to interested outside investigators, stored for later off-line viewing
Number of on-site participants expected: 60
Complete file and slideset: FDA-NHLBI-Tutorial 2010.zip ( 5 MB)
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
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
Annette Stine, RN, Research Coordinator
Live Webcast and Video Archive
Guidance documents on medical devices and radiation emitting products:
Medical Devices and Radiation-Emitting Products
- How to prepare an IDE:
Device Advice: Investigational Device Exemption (IDE)
And sublink for IDE content:
- 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- Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications.
- Draft Guidance for Industry and FDA Staff: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)]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.
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff.
- 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