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U.S. Department of Health and Human Services

For Industry

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What protocol needs to be followed to get a medical device approved?

There are three Steps to Obtaining Marketing Clearance from CDRH. They are:

STEP ONE in the marketing process is to make absolutely sure that the product that you wish to market is a medical device, that is, does it meet the definition of a medical device in section 201(h) of the FD&C Act. For example, the product may be a drug or biological product that is regulated by a component in the FDA other than the Center for Devices and Radiological Health (CDRH) and for which there are different provisions in the FD&C Act. Or your product may be a medical device and is also an electronic radiation emitting product with additional requirements.

STEP TWO is to determine how FDA may classify your device - which one of the three classes the device may fall into. Unless exempt, FDA will classify your device. Classification identifies the level of regulatory control that is necessary to assure the safety and effectiveness of a medical device. Most importantly, the classification of the device will identify, unless exempt, the marketing process (either premarket notification [510(k)] or premarket approval (PMA)) the manufacturer must complete in order to obtain FDA clearance/approval for marketing.

STEP THREE is the development of data and/or information necessary to submit a marketing application, and to obtain FDA clearance to market. For some [510(k)] submissions and most PMA applications, clinical performance data is required to obtain clearance to market. In these cases, conduct of the trial must be done in accord with FDA's Investigational Device Exemption (IDE) regulation, in addition to marketing clearance.

For more information on this process, please visit the Device Advice website.

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