This IDE (Investigational Device Exemption) webinar will cover its purpose and preparation recommended subject headings and content Submission and follow up Usage in the clinical trial(s).
The U.S. FDA requires an IDE (Investigational Device Exemption) to be developed for any new product that is to be involved in clinical trials. This affects not just FDA Class III PMA devices, but increasingly many FDA Class II devices subject to 510(k) Premarket notification and clearance.
The U.S. FDA requires an IDE (Investigational Device Exemption) to be developed for any new product that is to be involved in clinical trials. This affects not just FDA Class III PMA devices, but increasingly many FDA Class II devices subject to 510(k) Premarket notification and clearance.
Areas Covered in the seminar:
- The purpose of the IDE (Investigational Device Exemption).
- Expectations of the FDA.
- Its preparation - recommended subject headings and content Submission and follow up Usage in the clinical trial(s) - The IRB and 'Informed Consent'.
- What you can and can’t do with product prototypes and their labeling Use in a follow-on 510(k).
Who Will Benefit:
- Sr Management
- R&D
- Engineering
- Marketing
- QA/RA
- Clinical trial administrators/monitors
Course Provider
John E Lincoln,
