Investigational Device Exemption applications

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. 

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. 

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. 

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

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)... 

As summarized by the FDA, an investigational device exemption (IDE) allows a device to be used in a clinical study to collect safety and effectiveness data required to support a PMA application or a Premarket Notification [510(k)j submission to FDA. All clinical evaluations of investigational devices must have an approved IDE before a clinical study can be initiated. 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 Eood, Drug, and Cosmetic Act that would apply to devices in commercial distribution (FDA, 2009). 

The purpose of this document is to list the data needed for orthopedic devices containing UHMWPE. These data should be included in premarket notifications (510k), Investigational Device Exemptions (IDE) applications. Premarket Approval (PMA) applications, reclassification petitions, and master files to aid FDA in determining the substantial equivalence and/or safety and effectiveness of UHMWPE in implantable orthopedic devices. In this document UHMWPE is referred to as polyethylene (PE). 

For a significant risk device, as defined in the FDA s regulations, the sponsor must submit an application to the FDA for approval to conduct a clinical investigation. This application seeks an Investigational Device Exemption. When the manufacturer believes that there are sufficient data to establish the safety and effectiveness of its device, the manufacturer files a PMA. 

Guidance for Industry and Food and Drug Administration Staff (2012) The content of investigational device exemption (IDE) and premarket approval (PMA)—applications for... 

The EPA defers to the FDA in this determination. pp follows the FDA s examples of when the FDA begins regulating a product this occurs when an application for exemption for an investigational use of a new drug, animal drug, or device is submitted. ... 

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