Contact Lens (Mis)Labeling as Misbranding and Overwarning
Citation
Contact Lens (Mis)Labeling as Misbranding and Overwarning (1996 Third Year Paper)Abstract
One of the most important functions of the Food and Drug Administration (FDA) is the administration of labeling requirements promulgated pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA). This function is especially important in the area of medical devices. Although consumers may use such devices on a routine basis, most lack both the scientific knowledge to adequately inform themselves of the risks of device usage and the resources to keep abreast of developments in the device field. But protecting consumers involves more than merely informing them of risks. The FDA has also sought to restrain its regulatory power in this area in order to provide device manufacturers with the flexibility needed to innovate and to ensure widespread device distribution. Any FDA decision in the device labeling context, therefore, inevitably involves the weighing of these two often contradictory goals.Terms of Use
This article is made available under the terms and conditions applicable to Other Posted Material, as set forth at http://nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of-use#LAACitable link to this page
http://nrs.harvard.edu/urn-3:HUL.InstRepos:8889441
Collections
- HLS Student Papers [498]
Contact administrator regarding this item (to report mistakes or request changes)