The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA).
Why should you Attend:
To gain a fundamental understanding of FDA regulation of medical device software.
Areas Covered in the Session:
Definition of medical device software
FDA's medical device software regulatory scheme
Level of concern
Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University.
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