Medical Device Companies May Soon be required to Submit Adverse Event Data in Electronic Form

Published By : 19 Jun 2015 | Published By : QYRESEARCH

Importers and manufacturers of medical devices are being reminded by the United States Food and Drug Administration (FDA) about an impending requirement that will need all companies to submit data reports on adverse events electronically.

The move from paper to electronic submissions was finalized in February 2014 under a rule titled “Medical Device Reporting: Electronic Submission Requirements.”

Manufacturers of medical devices have since long been required to report suspected or unknown adverse events to the Food and Drug Administration under 21 CFR 803. However, the regulating body has been accepting reports in paper forms traditionally (Form 3500A).

Nevertheless, similar to the many other forms being submitted to the FDA, the US agency is shifting towards a standard of electronic submission. The argument put forth is that digital submission is cheaper, faster, more precise, and enables better reporting and analysis. 

Under the new rule, importers and manufacturers of medical devices will now have only two electronic alternatives to report MDRs to the Food and Drug Administration: One for reports in batches by way of the tool Health Level 7 Individual Case Safety Reporting (ICSR) and the other for single reports with the help of the eSubmitter tool. 

The use of 3500A, or the paper based form of the FDA, will now be limited only to user facilities such as hospitals. 

One significant feature of the Food and Drug Administration’s February 2014 rule was the period of time the regulating agency said it would grant companies manufacturing and importing medical devices to adapt to the rule: approximately 18 months. 

The revised rule of the FDA is intended to come into effect on August 14, 2015, after which all MDR submissions will need to be submitted in an electronic or digital format. 

The Food and Drug Administration said that manufacturers of medical devices may commence testing their adverse event report submissions by as early as June 29, 2015.
Back To Top