FDA 510(k) Clearance

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is safe and effective (substantially equivalent) to a lawfully marketed device that is not subject to premarket approval (PMA). Any medical device manufacturers or firms planning to market Class I, Class II and Class III medical devices in the United States intended for human use must obtain 510(k) clearance, if Pre-market Approval is not required.

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During the review of the 510(k) technical dossiers, if the FDA finds the device as Substantially Equivalent to a legally marketed device, the FDA will give the 510(k) clearance with a ‘(k)’ number. The “(k)” number has 6 digits. First two number following “k” represents calendar year in which 510(k) submission is received and next 4 digits represents the submission number starting from 0001 in that calendar year and increase in chronological order with each new submission.

 

510(k) clearance is not required for all the devices. Most of the Class I medical devices and few Class II devices are exempted from 510(k) requirements. FDA doesn’t inspect the facility to provide 510(k) clearance.

 

FDA Centers which Clear 510(k)

Two centers in US FDA regulates medical devices. Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER).

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CDRH: Center for Devices and Radiological Health

FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel and/or import medical devices sold in the United States.

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CBER: Center for Biologics Evaluation and Research

FDA's Center for Biologics Evaluation and Research (CBER) regulates Medical devices involved in the collection, processing, testing, screening, manufacture and administration of blood, blood components, human tissue and cellular products.

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Based on the nature of the medical devices 510(k) files shall be submitted to the respective centers.