| This thesis answers the question can design controls, as outlined in 21 Code of Federal Regulations 820.30, prevent another poorly designed medical device such as the Bjork-Shiley Convexo-Concave heart valve prosthesis from entering the market? The question is answered in the affirmative; design controls are effective. It reviews the history of the Convexo-Concave valve, and the parallel history of the Food and Drug Administration through the years 1960 through 1997. It also compares the 1976 FDA Good Manufacturing Practices law with the 1996 FDA Quality System Regulation regarding design controls, and outlines the major differences between the two regulations. Furthermore, a gap analysis is performed between information provided to the FDA by Shiley in 1978 and the current design control elements. Lastly, this thesis will point out the major lapses of ethics that were displayed by Shiley, Inc. and Dr. Viking Bjork. |
