Obtaining an FDA Investigational Device Exemption

Overview:

Clinical testing and studies of effectiveness are often needed to demonstrate that new medical devices are reasonably safe and effective. The participation of human subjects in these studies often implies some degree of risk and outcomes which are necessarily unpredictable. It is essential, therefore, that the rights, safety, and welfare of the subjects be protected. The instrument by which this is accomplished is the Investigational Device Exemption (IDE).

We will discuss here the conditions under which this protection is necessary, the means by which the IDE rules can be met while considering the degree of risk involved, and the means by which an approved IDE can be obtained. Interpretation of the IDE rules requires a precise knowledge of the terminology used, such as "medical device," "intended use," "Institutional Review Board (IRB)," "sponsor," "investigator," and "informed consent." We will define these terms and explain how subtleties of the definitions affect the interpretation of the rules. We will discuss the situation of the "sponsor/investigator," where a person doing research is sponsoring the research as well. This might be a physician who has designed a new instrument to be used in his practice, or an inventor doing a preliminary evaluation of his invention using human subjects. The situation in which a physician uses a legally-marketed device for a purpose other than that which it is intended will also be considered. The concept of "non significant risk" is important in this context. The developer of a new medical device typically will sponsor an investigation to demonstrate the safety and effectiveness of the device to the satisfaction of the FDA. The sponsor assumes the primary responsibility for compliance with IDE rules. These investigations usually involve multiple investigators and multiple institutions and the sponsor’s responsibilities include the activities necessary to coordinate a coherent investigation. An IDE application prepared by a sponsor will include a plan that assures all investigators are qualified, establishes a uniform protocol, identifies all the institutions and their IRB’s, and in general assures that investigators comply with the IDE rules.

Why should you attend: Anyone who intends to conduct research with human subjects that involve a medical device must comply with requirements of the Food, Drug and Cosmetic (FD&C) Act. The FD&C Act prohibits the distribution of devices that have not been cleared for marketing by the Food and Drug administration unless the distributor has an approved Investigational Device Exemption (IDE). This requirement applies to the person sponsoring the investigation or to an investigator who sponsors his own research. The purpose of IDE rule is to assure that the rights, safety and welfare of the subjects are protected. Anyone who conducts medical device research using human subjects without conforming to the FD&C Act may be guilty of "misbranding," which as prohibited Act punishable by fine and imprisonment.

Areas Covered in the Session:

• Definition of "Medical Device"
  
• Meaning of "Intended Use"
  
• "Research" vs. " Treatment
  
• Institutional Review Boards
  
• 21 CFR 812
  
• An IDE Without an FDA Application
  
• The Sponsor - Investigator Relationship
  
• Contents of an Application for an IDE
  
• The Investigational Plan
  
• Device "labeling" defined, required
  
• Informed Consent Requirements
  
• Laboratory Data
  
• Time Frame for FDA Response
  

• Medical device developers
  
• Physicians conducting research
  
• Hospital Administrators
  
• Biomedical Engineers
  
• Biomedical Engineering department chairs
  
• Students doing human research