Healthy Skepticism Library item: 11588

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Pena C, Bowsher K, Costello A, De Luca R, Doll S, Li K, Schroeder M, Stevens T.
An overview of FDA medical device regulation as it relates to deep brain stimulation devices.
IEEE Trans Neural Syst Rehabil Eng 2007 Sep; 15:(3):421-4
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17894274

Abstract:

The United States Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of a variety of medical products and the FDA’s Center for Devices and Radiological Health is responsible for premarket and postmarket regulation of medical devices. In this paper, we review—from device classification and clinical studies to the final marketing application—FDA’s premarket requirements and postmarket requirements as they relate to deep brain stimulation devices.

Keywords:
PMID: 17894274 [PubMed - in process]