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.

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.

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