The proposal—whether it will soon be implemented or not—has manifested the obvious drive FDA has toward automated systems. For example, once FDA is fully automated industry will have two options for electronic submission of MDRs including one for low volume reporting and another for its high volume counterpart. Industry will also benefit by "doing business" with an agency that will be far more efficient in terms of data collection, response, feedback and analysis. Those benefits alone will be a positive boon to industry.
If industry is required in the near future to submit eMDRs electronically industry will find it necessary to customize or purchase out-of-the-box quality and document control systems.
To learn more about the FDA's proposal to amend regulation 21 CFR Part 803 please visit: http://www.fdanews.com/ext/files/E9-19683.pdf or submit comments electronically at the Federal eRulemaking Portal.