Description of the origin of 510K, pre-market submission, pre-marked notification to FDA

1. The origin of term 510K The term 510k originates from the Federal Food, Drug, and Cosmetics Act (FD&C Act). This legislative act contains 20 chapters. Chapter V of FD&C Act, Drugs and Devices, regulates drugs and medical devices including in vitro diagnostic devices (IVD). Paragraph (k) of Section 510 of Chapter V of FD&C Act, Registration of Producers of Drugs and Devices, says the following: (k) Report preceding introduction of devices into interstate commerce. Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use shall, at least ninety days before making such introduction or delivery, report to the Secretary or person who is accredited under section 523(a) (in such form and manner as the Secretary shall by regulation prescribe). So, the term 510K is a cipher that guides you to a specific paragraph in FD&C Act. 510K is also called either a pre-market submission made to FDA or pre-market notification (PMN). MehisPold, M.D. mehisp@hotmail.com Copyright© Eomix, Inc.