FDA Requires Electronic Submission Of Adverse Event Reports By August 2015
This article was originally published in The Gray Sheet
Executive Summary
The new regulation applies to all device manufacturers and importers, regardless of their size. FDA increased its previously proposed one-year compliance window to 18 months in response to company input.
You may also be interested in...
With eMDRs On The Way, Many Firms Are Updating Complaint Handling Systems
Some manufacturers are using the advent of FDA’s electronic Medical Device Reporting (eMDR) program as an opportunity to upgrade their complaint handling systems.
Device Firms Want Two Years To Comply With Electronic MDR Rule
Covidien, AdvaMed and the Medical Imaging and Technology Alliance are asking FDA to give device manufacturers two years to comply with an upcoming rule requiring adverse event reports to be submitted to the agency electronically
Electronic Adverse Event Reporting Would Be Mandatory Under FDA Proposal
Device manufacturers would have to submit adverse event reports to FDA electronically under a draft rule issued Aug. 20