Five Year Review of Class I Medical Device Recalls: 2004-2008

摘要

Medical device manufacturers--as are all manufacturers of prescription products--are regulated by a variety of laws codified in Title 21, Chapter 9 of the U.S. Code and implemented by U.S. Food and Drug Administration (FDA). One statutory obligation is to monitor the safety of a prescription product and, based on this review, determine whether a product might have to be recalled. Recalls of medical devices have a widespread impact on all the participants involved. For the companies that manufacture and distribute medical devices, a recall can have an appreciable and sudden impact on its operations, the public image (goodwill), and the value of the company. Medical professionals must also deal with the effect of recalls as they are challenged with health decisions for their patients and choices of treatment. Lastly, patients are also affected by medical device recalls whether the device is implanted or used externally,on a regular basis to monitor or maintain their health.