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Quality Digest

FDA Compliance

New Software for Electronic Submission of Medical Device Reports to FDA

Published: Tuesday, March 27, 2007 - 22:00

(Sparta Systems Inc.; Holmdel, New Jersey) Sparta Systems Inc., the maker of TrackWise, and an enterprise quality and compliance process management software provider, has released the Beta version of the TrackWise eMDR Submission Manager software. The add-on software enables medical device companies to electronically submit medical device reports (MDR) to the Food and Drug Administration. TrackWise eMDR Submission Manager is one component of Sparta’s current initiative to support the growing number of life sciences electronic submission processes, which are complementary to quality and regulatory solutions. Medical device manufacturers use TrackWise to electronically track and manage product complaint and adverse event assessment and reporting processes. The software enables device companies to effectively manage complaints and investigations, assess potential adverse events for safety risk problems, and comply with health authority reporting requirements, including those of FDA.

FDA regulations require firms who have received complaints of device malfunctions, serious injuries, or deaths associated with medical devices to notify FDA of the incident. Manufacturers are required to submit an individual adverse event report (known as a MDR report) to FDA using its 3500A form. TrackWise customers currently produce 3500A reports in electronic form, from structured audit-trailed data fields. Sparta’s 3500A report has been previously approved by both FDA’s Center for Devices and Radiological Health and Center for Drug Evaluation and Research.

In an effort to streamline reporting of 3500A reports, FDA is now implementing an electronic submission program called eMDR. Under this program, FDA receives electronic submissions of MDRs via the FDA Gateway, a secure agencywide entry point for all electronic submissions. Using this approach, medical-device manufacturers can issue their reports electronically, eliminating costs and errors associated with paper-based reporting processes.

Sparta was asked by FDA to participate in its eMDR pilot program. Collaborating closely with the agency, Sparta has developed standard functionality within TrackWise that allows customers to electronically transmit MDRs through the FDA’s Secure Gateway.

“FDA’s eMDR Program and the TrackWise eMDR Submission Manager enable our medical device customers to improve their adverse event reporting processes by eliminating paper forms and manual document routing,” states Mike Jovanis, director of solutions architecture of Sparta. “TrackWise increases efficiency while approving accuracy of information, providing a better and more effective product safety process, which ultimately benefits consumers and patients.”

The new functionality, TrackWise eMDR Submission Manager can be added to existing and new TrackWise deployments. Several of Sparta’s larger device clients are already working with Beta versions of the functionality, and are planning to begin submitting MDRs electronically upon completion of the beta program.

For more information, visit www.sparta-systems.com/news%2Dand%2Devents/press%2Dreleases/022007.shtml.


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