ich, (a) are intended for surgical implant into the body, or (b) support or sustain life, and (c) whose failure to perform when properly used in accordance with instructions for use provided in the labeling, can be reasonably expected to result in a significant injury of the user. 2. A critical component in any component of a life support device or system whose failure to perform can be reasonably expected to cause the failure of the life support devi.