NEW SOFTWARE FOR ELECTRONIC MDRS
Sparta Systems released a new version of its software that allows companies to electronically submit their medical device reports (MDRs) to the FDA, the company announced.
A device firm that receives complaints of adverse events relating to its products must submit an MDR report to the FDA using a 3500A form. Sparta's beta version of its TrackWise eMDR submission manager software will work with current TrackWise software that produces 3500A reports in electronic form.
Sparta said it collaborated with the FDA to develop standard functionality within TrackWise. CDRH and the FDA's Center for Drug Evaluation and Research have already approved Sparta's 3500A report form, the company said.
The FDA asked Sparta to participate in its electronic submission program, under which the agency will receive eMDRs through the FDA Gateway, a secure agencywide entry point for all esubmissions, the company said.