Compassionate use without an IDE

Ashton Steinhagen, Lead Clinical Research Associate for IMARC Research What happens if you have a site that requests to use an unapproved device that could be life-saving for a patient without an Investigational Device Exemption (IDE)?  The device has been through the phases of clinical trials and the Sponsor is working on submitting the premarket approval (PMA).  The site in question was part of that clinical trial but now the study and enrollment goal has been met and both the site and study are closed. According to a response by a consumer safety officer at the FDA, there are two options for compassionate use cases; one with an IDE and one without an IDE. The specific criteria for compassionate use cases states that “the patient has a life-threatening or serious disease or condition; and no generally acceptable alternative treatment for the condition exists.”  The following criteria for compassionate use with an IDE, noted from the FDA’s website, are as follows: A description of the patient’s condition and the circumstances necessitating treatment; A discussion of why alternative therapies are unsatisfactory and why the probable risk of using the investigational device is no greater than the probable risk from the disease or condition; An identification of any deviations in the approved clinical protocol that may be needed in order to treat the patient; The patient protection measures that will be followed: A draft of the informed consent document that wi...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog IMARC Source Type: news