Description
Summary:
Describes a procedure for handling physician requests for use of ¿unapproved¿ systems in the case of a compassionate plea. Applies to requests from US-based physicians only. Covers evaluation criteria, documenting approval, cross-reference letters, obtaining FDA approval, and providing follow-up information. Includes provisions for compliance with applicable FDA regulations.
Included Sections:
Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures
Included Attachments/Appendices:
Compassionate Plea Check List and Information, Directions for Requesting A Single Use Investigation Device Exemption (IDE)
About This Document:
This is not a generic template, it's a 5-page procedure that was actually created and used in the Clinical Research operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.
Reasons to Buy:
- Use it as a starting point for your own documentation project
- Compare the quality of your documents against your industry peers
- Learn what other companies in your industry are actually doing
Who Will Benefit:
- Clinical Research Associates
- Clinical Study Managers
- Regulatory Affairs Personnel
Product Details
- Edition:
- 1.0
- Published:
- 08/01/2007
- Number of Pages:
- 5
- File Size:
- 1 file , 330 KB
