Sparta releases tool for electronic FDA medical device submissions
Enterprise quality and compliance process management software provider Sparta Systems has released the Beta version of its TrackWise eMDR Submission Manager software. The add-on enables medical device companies to electronically submit Medical Device Reports (MDRs) to the FDA.
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 dubbed "MDR Report" to the FDA using its 3500A form.
However, the FDA has streamlined the process by implementing an electronic submission program called eMDR. Under this program, FDA receives electronic submissions of MDRs via the FDA Gateway, a secure agency-wide entry point for all electronic submissions.
Sparta was asked by FDA to participate in its eMDR pilot program, in collaboration 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," said Mike Jovanis, director, 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 both existing and new TrackWise systems.
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 dubbed "MDR Report" to the FDA using its 3500A form.
However, the FDA has streamlined the process by implementing an electronic submission program called eMDR. Under this program, FDA receives electronic submissions of MDRs via the FDA Gateway, a secure agency-wide entry point for all electronic submissions.
Sparta was asked by FDA to participate in its eMDR pilot program, in collaboration 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," said Mike Jovanis, director, 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 both existing and new TrackWise systems.