Legal and ethical issues in the regulation and development of engineering achievements in medical technology. II

For pt.I see ibid., vol.9, no.2, p.79-81 (1990). The ethical issues raised by the fact that patients/subjects are less protected in non-investigational-device-exemption (non-IDE) use of unapproved medical devices than in IDE use are examined. Practice, research, and nonvalidated practice, an intervention that falls into the region between pure practice and pure research, are defined and examined with respect to non-IDE use of unapproved medical devices. Two types of non-IDE use are considered: that which would be permitted under the feasibility studies mechanism, and emergency use. Ethical issues in both cases are discussed. It is concluded that the Food and Drug Administration (FDA) must not only expand the freedom of scientific investigators to develop new medical devices, allowing flexibility in defined non-IDE contexts that will not jeopardize the safety or welfare of patients, but also clearly and concisely define the procedures which outline this expanded freedom.