FDA Announces eMDR Enhancements

The U.S. Food and Drug Administration (FDA) has posted a list of pending enhancements to its online electronic medical device reporting system (also known as eMDR).

In an update to its website, the FDA identified 10 separate changes or enhancements to the eMDR, along with the anticipated dates of their implementation. The changes include adding or removing certain fields, updating certain electronic forms, and providing longer entries.

The FDA says that providing early notice of pending changes to its system is important for manufacturers submitting various reports to the agency, especially for those who have system-to-system (AS2) accounts that will require updates to the systems on their end to align with the planned changes.

The FDA requires that medical device manufacturers and importers submit medical device reports to the FDA in an electronic format through the eMDR, Hence, the importance of notifying impacted parties of the anticipated changes in advance.

Read additional details about the changes and enhancements to the FDA’s eMDR electronic medical device reporting system.

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