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February 24, 2016 - Updated 06.14.16

Clinical Trials; Device Classification

The most common types of submissions include:

IDE (Investigational device exemption):

The investigational device is allowed to be used in a clinical study in order to collect safety and effectiveness data. 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. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.

510(k) (Premarket Notification):

Some Class I and most Class II devices require a 510(k). In a 510(k), the sponsor must demonstrate that the new device is "substantially equivalent" to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed

PMA (Premarket Approval):

Most Class III devices require a PMA. A PMA is the most stringent type of premarket submission. Before the FDA approves a PMA, the sponsor must provide valid scientific evidence demonstrating reasonable assurance of safety and effectiveness for the device's intended use.

PMR (Postmarketing requirements):

include studies and clinical trials that sponsors are required to conduct under one or more statutes or regulations. Postmarketing studies or clinical trials to demonstrate clinical benefit for drugs approved under the accelerated approval requirements in 21 CFR 314.510 and 21 CFR 601.41

PMC (Postmarketing commitments):

are studies or clinical trials that a sponsor has agreed to conduct, but that are not required by a statute or regulation.

HDE (Humanitarian Device Exemption):

HDE provides a regulatory path for Class III devices that are intended to benefit patients with rare diseases or conditions. In order for a device to be eligible for an HDE, a sponsor must obtain designation as a Humanitarian Use Device (HUD), which is granted through application to FDAs.

PMAs, HDEs and some 510(k)s require clinical evidence. Prior to initiating a clinical study, the study sponsor may need to obtain approval of an Investigational Device Exemption (IDE) by the FDA. The study will also need to be approved by the appropriate Institutional Review Board (IRB). Clinical studies must comply with all applicable IDE regulations and Good Clinical Practices (GCPs).

If a device requires premarket clearance or premarket approval prior to marketing (i.e., the medical device is not exempt), the device firm must wait until it receives FDA clearance or approval before registering and listing. Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote clearance or approval of the establishment or its products by the FDA.

***NOTE: You are required to submit IDE and HDE studies for Medicare approval. All other studies will follow FDA requirements and do NOT require Medicare approval. If the IDE portion of the study is completed/closed clinical trial modifiers or ICD10s are not required on your claim***

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