Investigation device exemption

Investigational New Drug Applications (INDs), NDAs, Premarket Approval Applications (PMAs), Premarket Notifications (5 lO(k)s), Investigational Device Exemptions (IDEs), Biological Master Files (BMFs) and DMFs that are referenced in the current application. 

The conduct of studies of medical devices in the US that have not been cleared/ approved by the FDA is regulated via Investigational Device Exemption (IDE) regulations set out in 21 CFR Part 812. Considering the type of device and the level of associated risk involved, investigations maybe conducted as IDE-exempted studies. Abbreviated requirement studies, or studies subject to full IDE requirements. 

Investigational Device Exemptions - 21 CER Part 812 Pre market approval - 21 CFR Part 814... 

Purpose The mission of the National Institute of Neurological Disorders and Stroke (NINDS) Office of Translational Research is to facilitate the pre-clinical discovery and development of new therapeutic interventions for neurological disorders. The Office supports pre-clinical projects from the discovery of candidate therapeutics through IND and Investigational Device Exemption (IDE) applications to the FDA. This is accomplished through both access to NINDS contract resources and direct funding mechanisms. 

Invert oil-emulsion muds, 9 5 In-vessel composting, 25 874 Investigational Device Exemption (IDE), 21 577... 

F. Premarket Notification, Investigational Device exemptions including Humanitarian Exemptions, Premarket Approval, Product Development Protocols, Classification, Device Tracking, Petitions for Reclassification, postmarket surveillance under Sections 510(k), 513, 515, 519, 520(g) and (m), and 522, and the advisory committees necessary to support these activities. 

Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required... 

Investigational Device Exemption (IDE), Humanitarian Device Exemption (HDE), or Premarket Approval (PMA) numbers for device trials... 

An application for an investigational device exemption, described in part 812. 

U.S. Food and Drug Administration. Office of Health and Industry Programs. Division of Small Manufacturers Assistance. Project Officers James Park, Marsha Melvin, Althea Barcome. Investigational Device Exemptions Manual. HHS Publication FDA 96-4159. Rockville, MD U.S. Department of Health and Human Services, 1996. 

BLA—Biologies License Application (eCTD and eBLA format) eCTD—Electronic Common Technical Document IDE—Investigational Device Exemption IND—Investigational New Drug Application (eCTD and eIND format)... 

Includes information for medical devices general, labeling, reporting, in vitro diagnostic products, investigational device exemptions, premarket approval, postmarket surveillance, and classification procedures. 

An investigational device exemption (IDE) is required for a device that will be used in clinical trials to support a PMA submission. IDE s are also required for clinical evaluation of certain modifications to or new intended uses of legally marketed devices. An IDE may be granted by the Institutional Review Board (IRB) at the facility where the investigational study will take place. The FDA must also approve the IDE if significant risk is involved. 

The premarket approval process must in most cases begin with a clinical trial, and its requirements are included in the following sections on Investigational Device Exemptions. The Investigational Device Exemption/Premarket Approval process is not a trivial undertaking. It will likely take three to five years to complete (see Fig. 1). 

All clinical studies performed in the U.S. in support of a 510(k) or PMA must be conducted in accordance with the Investigational Device Exemption (IDE) regulation (21 CFR Part 812). 

Class III transitional devices, i.e., devices considered to be a new drug or antibiotic drug before May 28, 1976, and new devices are automatically classified into Class III by statute and require premarket approval by FDA before they may be commercially distributed. Applicants may either submit a PMA or PDP, or they may petition FDA to reclassify the devices into Class I or II. Clinical studies in support of a PMA, PDP, or a reclassification petition are subject to the Investigational Device Exemption application. 

Currently, the CoreValve still awaits FDA approval for an investigational device exemption (IDE) to initiate a clinical trial in the United States. In the meantime, Medtronic, Inc. (Minneapolis, MN) announced acquisition of CoreValve on February 23, 2009. Given Medtronic s longstanding involvement in the prosthetic valve technology, this transaction will certainly further help facilitate future clinical program developments of the CoreValve Revalving system in the coming years. 

The clinical data submitted in a PMA is generated under an Investigational Device Exemption (IDE). An IDE contains information on previous clinical studies with the device, design, manufacture, and control of the device, the investigators who will conduct the study. The FDA must approve the IDE prior to the start of the clinical study and make a determination on the approvability of an IDE within 30 days of receipt (19-22). 

---