|Minimum Order Quantity||50 Unit|
510 (k) Certification Service of the Food, Drug, and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.
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. Operon Strategist helps the client in the classification of the device after consultation with the client. After conferring with the client, we establish the predicate device & testing requirements as per US FDA consensus standards. We help in the 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.
|Minimum Order Quantity||2 Set|
|Company Type||Medical Industry|
|Industry||Manufacturing, Chemical, Drug|
Being a leading service provider in this domain, we are engaged in providing USFDA Certification Service in the US to our clients. This USFDA Certification Service is provided by expert professionals. This USFDA Certification Service is provided by our skilled professionals and responsible for protecting and promoting public health through the regulation and supervision of food and other relate items. Our service range is widely demanded in different regions.
Why US FDA