About the Feature
When generating FDA MedWatch 3500A forms, more device-specific fields and Combination Product scenarios are supported. The fields that can now be exported include the following:
- C.7. Is the Product Over-the-Counter?
- G.5. OTC
- H.3. Device Evaluated by Manufacturer
- H.9. If action reported to FDA under 21 USC 360i(f), list correction/removal reporting number
- H.10. Additional Manufacturer Narrative
Although this feature is automatically available, you may need to update your Case Product page layouts to use the new Device Information fields.
After configuring the page layout, see Enter Case Data: Device Information Section for more information.
Update the Case Product Page Layout
Add the new Device Information fields to the following Case Product page layouts:
- Company Product Detail Page Layout
- Device Detail Page Layout
- Go to Admin > Configuration > Objects > Case Product > Page Layouts.
- Select the page layout you want to update.
- In the Device Information section, add the following fields:
- Correction/Removal Reporting Number
- Additional Device Manufacturer Narrative
- Select Save.
