What is 510(k)?

510(k) Definition

Section 510(k) of the FD&C Act (amended on May 28, 1976, to include medical devices) requires device manufacturers who must register to submit a premarket notification (PMN) to the FDA, informing them of their intent to market a medical device at least 90 days in advance. A PMN helps the FDA determine whether a device is equivalent to one already placed into one of the three classification categories or if it’s a new device.

510(k) Timeline

Related Terms

  • Class I Device
  • Class II Device
  • Class III Device
  • FDA
  • Medical Device
  • Premarket Notification (PMN)