510K – Understanding the Facts About the Pre-Market Notifications

All the companies planning to introduce a medical device in the US market need to submit an application to the FDA called a 510K. The 510K submission is needed for Class I devices, nearly all Class II devices and a very small number of Class III devices. As per the FDA Act, the FDA recognizes three classes of medical devices, based on the level of control necessary to assure safety and effectiveness.

The FDA 510K submission process is a procedure that works in a few simple steps.

The first step of the 510K process is to confirm the classification of the product and to identify whether it qualifies as a medical product for the FDA 510K process. The FDA classification database has a list of all the medical devices with descriptions provided. Once the classification of the device matches the descriptions provided in the database, the medical device is ready for the next step of FDA 510K approval.

The next of the 510K process for medical devices is to compare the medical product that needs 510K clearance with a device already cleared by the 510K approval process (called the predicate device)for sale in the US. The predicate devices are listed in the 510K FDA database, along with the FDA regulation number, classification product code and the predicate 510K number.

Now, one has to check against the classification product code of the predicate device and determine whether any standards guidance documents apply to the medical device as part of the FDA 510K approvals. These are additional FDA 510K requirements necessary as part of the 510K process.

After all safety and performance testing is finalized on the medical product as per the 510K compliance, one must prepare and submit the 510K submission to the FDA comparing the device to the predicate device.

The FDA will review the submission within 90 days, you submit the 510K submission. The FDA charges a fee to review the 510K submissions, and if successful, an FDA 510K clearance letter from FDA with a 510K approval number.

Once the medical device has been cleared as per FDA 510K requirements, and you have received the 510K number, it has to be registered with the FDA, and pay the annual fee to the FDA.

For the companies located outside the US, who want to introduce medical products in the US, a US Agent with 510K training will be needed to be hired to assist the companies to respond to the questions regarding the device and work with the FDA in scheduling inspections of the foreign establishment.

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