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.