Michael Causey, Editor & Publisher, eDataIntegrityReport.com
The FDA is anxious for eMDR to be formally launched with a full-blown regulation. It’s been delayed, (mostly for internal reasons having more to do with a change in Administration than the actual contents of the reg, we hear) but it’s ultimately a matter of “when, not if,” an eMDR guidance will arrive.
Savvy medical device and drug manufacturers are getting ahead of the curve and embracing eMDR. Others are waiting to be ordered to do it.
Don’t wait too long. You risk losing a competitive advantage, for starters. Did you realize that 11% of MDRs came via eMDR in CY 2008? Or that thirty manufacturers are currently submitting electronically via eMDR?
Yep, it’s the companies that view this as a way to improve efficiency, speed approvals, and improve overall product quality that will ultimately thrive in the marketplace, experts stress.
The FDA just did a nice job updating its user guide to its Electronic Submissions Gateway (ESG). It’s available here at http://www.fda.gov/esg/userguide/WebHelp/default.htm
- Submission prep guidelines can be found here http://www.fda.gov/esg/userguide/WebHelp/default.htm
- Finally, the FDA’s home page for all things ESG can be found here http://www.fda.gov/esg/
- Assurx also has an updated eBook on eMDR that can be found here http://www.assurx.com/emdrebook.html
- And the FDA’s own eMDR page is here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm127932.htm
