K Substantial Equivalence Determination

MEDICAL DEVICES: FDA regulatory pathways for ... - TOPRA

A traditional 510(k) application includes the device’s name, description, intended use, proposed label, as well as a comparison with a predicate device, and the device’s advertisement and directions for use,20 supported by preclinical studies. The term substantial equivalence, in many cases, means simply that the device performs in a similar

  Devices, Medical, Medical device, Equivalence, Substantial, Substantial equivalence