4 How to set up reporting destinations
Recommendations for creating the reporting destination required to send eMDR to the Center for Devices and Radiological Health (CDRH), if the submitter is a Manufacturer.
On the Agency Information tab
Enter the name and address information, as applicable.
The CDRH technical specifications recommends using CDRH_ESUBS as Agency Identifier.
Select the Manufacturer check box for the Contract Type field.
On the Local Company tab
Enter the name and address information of the Local Company Contract that is responsible for eMDR submission.
- Sender Type
- Department
- Contact Name information:
- Title
- First Name
- Last Name
- Address
- City
- State
- Postal Code
- Country
- Phone
- Fax
- Email Address
On the EDI tab
The CDRH technical specifications recommends using CDRH_ESUBS as Agency Identifier.
For the Message Profile field, select CDRH EMDR V1.0 MESSAGE TEMPLATE. This is the standard profile.
The ACK Profile option is disabled for eMDR.
Mark the Transmit ICSR Attachments option.
For Attachment Classification, mark one or more attachment classifications, depending on what is required for submission along with the eMDR.
The supported attachment file size is 15 MB and 50 MB for the report size.
Make sure to specify the outgoing folder location. Example:
C:\ESM\CDRH\OUT\.
Select the E2B EDI gateway Method.
Note:
If the eMDR submitter is an Importer or a Distributor, then follow the same steps as described above for Manufacturer. However, make sure that the Importer or Distributor check box is selected instead of the Manufacturer check box.