Category: FDA

Suffering from Medical Device Related Health Issues | Gear up now

Are you aware of the FDA reports of insulin pump causing severe health problems during 2006-2009? 310 persons in US out of them were claimed dead.  The total reports published by FDA were considering around 17,000 cases of health issues. Yes, the villains were some of the biggest manufacturers of insulin pump in USA. Most [...]

Friday July 23rd, 2010 in FDA | No Comments »

How to Conform To Medical Device Approval Standard by FDA

Medical devices sold in the United States are generally monitored by two centers within FDA (U.S. Food and Drug Administration) – CDRH, the Center for Devices and Radiological Health and CBER, Center for Biologics Evaluation and Research. What are CDRH and CBER? The first one (CDRH) regulates firms that produce, repackage, re-label, or import most [...]

Monday June 28th, 2010 in FDA | No Comments »

How FDA does approve Medical devices?

FDA observes reports of unfavorable events and other evils with medical devices and alerts health experts and the public when desired to ensure appropriate use of devices and the safety and health of patients. Well any types of medical devices that should be approved by the FDA and if is there any medical professionals or [...]

Monday May 31st, 2010 in FDA | No Comments »
Copyright © 2012 | Disclaimer