IDE Early/Expanded Access: Emergency Use
Emergency situations may arise in which there will be a need to use an investigational device in a manner inconsistent with the approved investigational plan or by a physician who is not part of the clinical study. Emergency use of an unapproved device may occur before an IDE is approved.
Criteria:
- Life-threatening or serious disease or condition
- No alternative
- No time to obtain FDA approval
Time-frame: Before or after initiation of the clinical trial
Featured Products
ISO 13485 Internal Auditor Checklist
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Best Practices for Maintaining an IND and IDE Application with FDA
IND and IDE annual reports - Amending clinical protocols and informed consent – Format, Content, Editing, Submission of Documents
IND and IDE annual reports - Amending clinical protocols and informed consent – Format, Content, Editing, Submission of Documents
IDE (Investigational Device Exemption) for PMA and 510(k) for CDRH and CBER
Meetings with FDA - Sample Size Considerations - Inclusion/Exclusion Criteria - End Points - Case Report Forms - Administrative Plan
Meetings with FDA - Sample Size Considerations - Inclusion/Exclusion Criteria - End Points - Case Report Forms - Administrative Plan
The IDE (Investigational Device Exemption) - It's Purpose and Preparation
The purpose of the IDE – FDA Expectations – preparation – recommended subject headings – content submission - follow up Usage in the clinical trial
The purpose of the IDE – FDA Expectations – preparation – recommended subject headings – content submission - follow up Usage in the clinical trial
Planning for a Successful Pre-IDE Meeting with FDA
Pre-IDE Meeting – Process- Submission preparation - presentation
Pre-IDE Meeting – Process- Submission preparation - presentation
