Investigational Device Exemption
Encyclopedia
An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study
in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a
Premarket Notification [510(k)] submission to Food and Drug Administration
(FDA). Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.
Clinical evaluation of devices that have not been cleared for marketing
requires:
An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that would apply to devices in commercial distribution. Sponsors need not submit a PMA or Premarket Notification, register their establishment, or list the device while the device is under investigation. Sponsors of IDE's are also exempt from the Quality System (QS) Regulation except for the requirements for design control.
A sponsor of a significant risk device study must submit a complete IDE application to FDA. There are no preprinted forms for an IDE application; however, an IDE application must include certain required information. The sponsor must demonstrate in the application that there is reason to believe that the risks to human subjects from the proposed investigation are outweighed by the anticipated benefits to subjects and the importance of the knowledge to be gained, that the investigation is scientifically sound, and that there is reason to believe that the device as proposed for use will be effective.
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a
Premarket Notification [510(k)] submission to Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA). Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.
Clinical evaluation of devices that have not been cleared for marketing
Marketing
Marketing is the process used to determine what products or services may be of interest to customers, and the strategy to use in sales, communications and business development. It generates the strategy that underlies sales techniques, business communication, and business developments...
requires:
- An IDE approved by an institutional review boardInstitutional review boardAn institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...
(IRB). If the study involves a significant risk device, the IDE must also be approved by FDA - Informed consent from all patients
- Labeling for investigational use only
- Monitoring of the study and
- Required records and reports
An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that would apply to devices in commercial distribution. Sponsors need not submit a PMA or Premarket Notification, register their establishment, or list the device while the device is under investigation. Sponsors of IDE's are also exempt from the Quality System (QS) Regulation except for the requirements for design control.
A sponsor of a significant risk device study must submit a complete IDE application to FDA. There are no preprinted forms for an IDE application; however, an IDE application must include certain required information. The sponsor must demonstrate in the application that there is reason to believe that the risks to human subjects from the proposed investigation are outweighed by the anticipated benefits to subjects and the importance of the knowledge to be gained, that the investigation is scientifically sound, and that there is reason to believe that the device as proposed for use will be effective.
See also
- Academic clinical trialsAcademic clinical trialsAcademic clinical trials are a valuable component of the health care system; they benefit patients and help determine the safety and efficacy of new drugs and devices....
- Adverse drug reactionAdverse drug reactionAn adverse drug reaction is an expression that describes harm associated with the use of given medications at a normal dosage. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs...
- Adverse eventAdverse eventAn adverse event is any adverse change in health or side effect that occurs in a person who participates in a clinical trial while the patient is receiving the treatment or within a previously specified period of time after the treatment has been completed.AEs in patients participating in...
- Approved drugApproved drugIn the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo an extensive FDA approval process. This process involves first testing the drug on animals or in medical labs. If found to be safe by the FDA and approved for the next phase of study, the drug is then...
- Assay sensitivityAssay sensitivityAssay sensitivity is a property of a clinical trial defined as the ability of a trial to distinguish an effective treatment from a less effective or ineffective intervention...
- BiotechnologyBiotechnologyBiotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts. Biotechnology also utilizes these products for manufacturing purpose...