FDA Plan for more Efficient Medical Device Recalls, Removal and Reporting Moves ForwardApr 23, 2014
The U.S. Food and Drug Administration (FDA) is moving forward with their plan to make the reporting of medical device removals and corrections easier, Regulatory Focus reports. In June 2013, the agency said that they wanted to make submissions of “806 reports” easier; these filings are used to report the correction or removal of a medical device from the market due to safety concerns. The FDA submitted their proposal for final government review this week.
Companies have to report corrections and removals to the FDA when a device is recalled because of a risk of human health or if the recall was initiated to “remedy a violation” of the Federal Food, Drug and Cosmetic Act that may pose harm to human health. It is required that these reports are submitted to the FDA within 10 days of the action, and must include 15 various data points such as communications regarding the device, marketing status and a description of events that took place leading up the removal or correction.
In the past, 806 reports were sent to the FDA in paper format by mail. This process is becoming outdated, especially since the agency has most of its forms available electronically. The FDA adverse event reporting forms, for instance, can be submitted online. If the FDA’s proposal is accepted, then this archaic process will change. Last June, the agency proposed an “electronic process for submitting 806 reports” voluntarily. Paper format reporting would still be accepted, but the electronic filing is expected to make things more efficient by enhancing the consistency of data.
"We believe that submitters will find the electronic submission process to be user friendly and that it will enhance the consistency of submission data," the FDA stated. "We estimate that an electronic report will take the same amount of time for the submitter as a paper report takes."
The electronic 806 reporting process would require users to set up a “WebTrader” account and a digital verification certificate, Regulatory Focus reports; these would be valid for three years and the process could take as long as two weeks. During that time, paper-based reports would need to be submitted. Other than the certificate, there would not be any cost associated with the electronic process.