by a govt regulatory agency, not restricted to FDA
Scope Note
Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.
Entry Term(s)
Device Approval Process
Food and Drug Administration Device Approval
Food and Drug Administration Device Approval Process
Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.
