Managing Batch Electronic Medical Device Reporting

Occasionally, you may want to submit multiple medical device reports as a batch. For example, if you are submitting 100 month-end reports, creating a batch enables you to submit reports in one transmission rather than 100 individual transmissions.

To create a batch e MDR and populate it with regulatory reports

1. Navigate to Regulatory Reports screen, then the eMDR Batch view.

   A list of existing eMDR batches will appear.

2. In the eMDR batch list, create a new record and complete the necessary fields.

3. For the new record, enter any unique alpha numeric string in the Batch # field.

4. Navigate to Regulatory Reports screen, then the eMDR view and do the following:

   1. Identify a regulatory report that you want to include in batch, and modify the Batch # field to the one specified in Step 3.

   2. Repeat Step a for every regulatory report that you want to include in the batch.

      This regulatory reports will remain in the eMDR queue and will be sent as part of a batch to the FDA at month end.

5. To transmit the batch immediately, do the following:

   1. Navigate to Regulatory Reports screen, then the eMDR Batch view,

   2. Select the batch created in Step 3, and then click Transmit.

Note: Once transmitted, you should monitor the FDA Status field of the batch for FDA confirmation. For more information on confirmation statuses, refer to About FDA Confirmations for Electronic Medical Device Reporting.