It was pointed out by Dr Shahbudin Rahimtoola that a misstatement occurred in the editorial by Vlahakes, “Mechanical Heart Valves: The Test of Time” (Circulation. 2007;116:1759–1760). Dr Vlahakes mistakenly stated that the US Food and Drug Administration approved the Starr-Edwards valve in 1965 and the St. Jude and Hall-Medtronic valves in 1977.
In fact, the Medical Device Amendment was signed into law by President Gerald Ford in May 1976. The final regulation was published on January 18, 1980, and these devices were approved by the Food and Drug Administration in the early 1980s.1
The author regrets these errors.
Reference 1 Rahimtoola SH, Rahmoeller GA. The law on cardiovascular devices: the role of the Food and Drug Administration and physicians in its implementation. Circulation. 1980; 62: 919–924.OpenUrl