510(k) Clearance & Premarket Approval

In US, the US FDA regulates the sale of medical devices. There are different regulatory controls for devices of different classes. For class I devices & some 510(k) exempted devices, there is establishment & registration & device listing.

Operon Strategist classifies the devices & gathers information about the company the products which is then uploaded through an online process.
For class II devices, there is a process called the 510(k) process or the pre-market clearance. In this, the safety & effectiveness of the device is established through substantial equivalence.

A 510(k) is a premarket submission made to FDA to show that the device to be advertised  is at least as safe and effective, 510(k) implies it is considerably equivalent to a legally marketed device and isn’t liable to PMA.

The legally marketed device(s) to which comparability is drawn is normally known as the “predicate.” Although devices recently cleared under 510(k) are regularly chosen as the predicate to which equivalence is guaranteed, any legitimately marketed device might be utilized as a predicate.

USFDA Medical Devices 510(k) File Submission
Operon Strategist helps client in classification of the device after consultation with the client. Thereafter, the 510(k) process is explained & the scope of work is explained. After conferring with the client, we establish the predicate device & testing requirements as per US FDA

consensus standards. We help in compilation of the 510(k) file, review of test reports, and submission of the file to US FDA & correspondence with US FDA.

We also help in handling the queries raised by the US FDA reviewer. We support the client until they receive the 510(k) clearance letter.

The 510(k) is Required For

Domestic manufacturers introducing a device to the U.S. market.

Repackers or relabelers who make labeling changes or whose operations significantly affect the device.

Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market.

A Manufacturer needs 510k when:

Anyone who wants to sell a device in the U.S. is required to make a 510(k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date.

Change in the intended use for a device which you already have in commercial distribution.

If there is a change or modification of a legally marketed device and that change could significantly affect its safety or effectiveness.

A new 510(k) submission is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or effectiveness of the device or the device is to be marketed for a new or different indication for use.

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