Health Care [N] » Environment and Public Health [N06] » Public Health » Consumer Product Safety » Device Approval
Analytical, Diagnostic and Therapeutic Techniques, and Equipment [E] » Investigative Techniques [E05] » Evaluation Studies as Topic » Device Approval
Description
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. MeSH
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