IDE Early Access: Treatment Use
An approved IDE specifies the maximum number of clinical sites and the maximum number of human subjects that may be enrolled in the study. During the course of the clinical trial, if the data suggests that the device is effective, then the trial may be expanded to include additional patients with life-threatening or serious diseases.
Criteria:
- Life-threatening or serious disease
- No alternative
- Controlled clinical trial
- Sponsor pursuing marketing approval
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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
