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About Regulatory Reports

From the time an adverse event or complaint is confirmed as reportable, companies generally have less than 30 days to report to a regulatory agency. An adverse event or complaint can be verified as reportable at various stages of the AECM process, from the initial customer call through to the review of the findings by the analysis team. Companies usually follow certain assessments that determine if an adverse event or complaint is reportable or not.

Separate reports have to be filed for each product that malfunctioned or caused the adverse event. Reports filed are based on the product issue, which typically contains much of the needed information. After the initial report, companies generally file additional supplemental, summary, and annual reports to update information on the investigation and resolution process.

The preconfigured Siebel AECM module supports MedWatch and MDV reports:

• MedWatch Reports. Using Siebel AECM, you can automatically generate MedWatch 3500A reports. Sections A to H of the report are populated from the relevant fields in the regulatory report record. The completed report can be saved and submitted electronically to the FDA using the electronic Medical Device Reporting (eMDR) process.

  For more information about eMDR refer to About Electronic Medical Device Reporting.

• MDV Reports. Medical device companies operating in multiple countries report adverse events or complaints to the various NCAs using the MDV form. Unlike MedWatch reports, there is no standard template for the MDV form. However, the Global Harmonization Task Force (GHTF) has guidelines.

  The report created by Siebel AECM follows these guidelines. For more information, see http://www.ghtf.org.

About Report Types

Table 35 details the four regulatory reports that can be created in Siebel AECM.

About Electronic Medical Device Reporting

For customers using the AECM process within the United States, you can submit an eMDR using the Siebel Business Application. Doing so transmits an XML message in HL7 ICSR format to the FDA. Moreover, you can also manage batch submission, and view their confirmation status by referring to the FDA Status field once they have been submitted.

The FDA has created a single system to accept individual, batch, and summary medical device adverse event reports by way of the FDA electronic gateway server. For additional information about the FDA electronic gateway server and FDA standards for eMDR from the FDA, refer to http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107914.htm.

For information about eMDR transmission using the Siebel Business Application, refer to Transmitting Electronic Medical Device Reporting Immediately, and Managing Batch Electronic Medical Device Reporting.

About FDA Confirmations for Electronic Medical Device Reporting

Once an eMDR or a batch eMDR has been transmitted to the FDA, the FDA Electronic Submissions Gateway (ESG) will respond to the submission. Depending on the processing state, the FDA Status field may be in any of the following three states:

• 1 of 3 - ESG. Indicates that FDA ESG has sent a Message Delivery Notification (MDN) to confirm that the submission was received. The message includes an official date received.
• 2 of 3 - ESG. Indicates that FDA ESG has sent an MDN to confirm that the submission has reached the Center for Devices and Radiological Health (CDRH).
• 3 of 3 - ESG. Indicates that CDRH has sent a message to confirm that the submission has been successfully loaded into the Adverse Event database, or that it has been rejected.

For information about eMDR transmission using Siebel Business Application, refer to Transmitting Electronic Medical Device Reporting Immediately, and Managing Batch Electronic Medical Device Reporting.