DOXPUB 09-0179-SOP

Summary:

Describes a procedure for collecting information regarding reportable events and filing the required reports. Specific to reporting to the U.S. Food and Drug Administration (see SOP 090178 for reporting to European Competent Authorities). Applies to marketed devices. Does not apply to products that are distributed under IDE in the United States. Covers definitions, time frames and reporting requirements, time frames for reporting a malfunction, cases where an event may not be reportable, cases where an event is definitely reportable, and documentation.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

None

About This Document:

This is not a generic template, it's a 6-page procedure that was actually created and used in the Regulatory Affairs 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:

• Regulatory Affairs Managers
• Management Representatives
• Executive Management