| |
 |
| |
| The Future Is Here: Electronic Medical Device Reporting |
By Nikki Willett,
Vice President of Marketing & Regulatory Affairs
Pilgrim Software, Inc.
from: Orthopedic Design & Technology
March/April 2008
Medical device manufacturers are required—through FDA 21 CFR Part 803—to submit medical device reports (also called MedWatch reports) when their devices are involved in patient safety issues or product malfunctions. The FDA receives more than 300,000 of these reports annually, and all of them used to be entered manually into the agency’s adverse event databases. Not any more. The FDA opened for business its electronic gateway for filing electronic medical device reports (eMDR). This optional program, intended to help the agency’s Center for Devices and Radiological Health (CDRH) identify patterns in adverse events more easily, as well as to reduce the overwhelming number of paper-based reports, is expected to become mandatory this spring.
Click here to read more.
E-mail
this page
Print This Page
|
|
|
 |
|
|
|
