Part 812 Investigational Device Exemptions

Question 1

Permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of thay device.

Answer 1

Approved Investigational Device Exemption

Question 2

A device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976

Answer 2

Transitional device

Question 3

Defined as the standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical investigations in a way that provides assurance that the data and results are credible and accurate and that the rights, safety, and well-being of subjects are protected

Answer 3

Good Clinical Practice (GCP)