When the Food and Drugs Act of 1906 was superceded by the Federal Food, Drug and Cosmetic Act, medical devices (and cosmetics) were subject to regulatory control for the first time. At least a major part of the pressure for passage of the 1938 Act was generated by the sulfanilamide disaster. As a consequence of that disaster provisions were made that new drugs could not be marketed unless they had first been shown to be safe for human use.
Date of Authorship for this Version
Field, Thomas G. Jr, "Informed Consent and the Investigational Use of Medical Devices: A Comparison of Common Law Duties with Those Imposed on Researchers Under Section 520(g) of the Medical Device Amendments of 1976" (1977). Pierce Law Faculty Scholarship Series. 22.