Industry News: FDA will Require Electronic Reporting of Adverse Events
For many years the FDA has required medical device/product manufacturers to report adverse incidents involving their devices or products. These adverse events are compiled into the FDA’s MAUDE database which is searchable on the FDA website. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. More information about the database is available from the FDA’s website.
At present all reports are submitted in paper form by mail, but under the new rule, manufacturers will now be required to submit the reports electronically in a compatible format (Health Level Seven). Details of this format and how to use it are available in an FDA Guidance document. Users will continue to report on paper.
These Medical Device Reporting: Electronic Submission Requirements, (eMDR), final rules will become effective on effective August 14, 2015. Further details of the rule are available in the Federal Register Notice. This rule is expected to increase efficiency and save both the FDA and the manufacturers significant costs.