FDA 510(k) Process

traditional fda 510k

Traditional FDA 510(k) for Medical Devices and IVD’s

Most Class II medical devices and a small number of Class I and Class III medical devices must undergo the FDA 510k process in order to obtain

abbreviated fda 510k

Abbreviated FDA 510(k) for Medical Devices and IVD’s

An Abbreviated FDA 510(k) relies on the use of summary reports which demonstrate your use of special controls or Declarations of Conformity to

special fda 510k

Special FDA 510(k) for Medical Devices and IVD’s

A Special 510k may be an appropriate submission for a modification to a medical device that already has an FDA 510(k) clearance. The Specia

traditional fda 510k sections

Sections Required for a Traditional FDA 510(k) Submission

The Traditional 510k submission is required for most new products and therefore is the most common type of application. The two-page summary

fda 510k fees

FDA 510k Fees and FDA Establishment Registration Fees

The US Food and Drug Administration charges a fee to review your 510k application. FDA 510(k) Application Review Fee (prices in US dolla