This paper will deal with with exemption granted [under the Medical Device Amendments Act of 1976] for the investigational use of devices subject to premarket testing, and more particularly, with the obligation of an investigator seeking such exemption to secure an informed consent agreement from human subjects (or their representatives) under § 520(g)(3)(D) of the Act. It will also consider the relationship between the statutory obligation and that which might be imposed by the common law of negligence.

Publication Date


Journal Title

IDEA: The Journal of Law and Technology

Document Type



Copyright 1977 by Commerce Clearing House, Inc.

Additional Information

This material was initially prepared for presentation at the Symposium on Medical Devices and Legal Responsibility held at the Massachusetts Institute of Technology on October 26, 1977. The present version of the article has been reprinted with minor changes from a version appearing in Volume 32 of the Food, Drug, Cosmetic Law Journal. It was also made available as Paper 22 in the Pierce Law Faculty Scholarship Series by NELLCO (nellco.org).