TheSilverSheet.com
Title
"The Silver Sheet" :: Medical Device Quality Control
Description
Excerpted from the website:
- LAST YEAR’S RISE IN MEDICAL DEVICE REPORTS may have been the result of more products on the market, as well as increased compliance with reporting regulations, CDRH’s Office of Surveillance and Biometrics says. More than 325,000 adverse events were reported to the agency’s MDR program in calendar year 2006 – an all-time high – and OSB staffer Indira Konduri expects the trend to continue. "At some point I’m sure it will plateau, but it definitely does look like this year and next, for sure, we’ll probably see an increase," Konduri says, noting that device recalls also may have played a part in the large volume of MDRs. Meanwhile, FDA clarifies MDR reporting requirements in a warning letter to Medtronic...
Languages
English
Additional Information
Related Domains
External Links
