Device Approval

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.

Year introduced: 1995

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Subheadings:

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Do not include MeSH terms found below this term in the MeSH hierarchy.

Tree Number(s): E05.337.275, N06.850.210.275

MeSH Unique ID: D018795

Entry Terms:

• Approval, Device
• Approvals, Device
• Device Approvals
• Device Approval Process
• Approval Process, Device
• Approval Processes, Device
• Device Approval Processes
• Process, Device Approval
• Processes, Device Approval
• Food and Drug Administration Device Approval
• Food and Drug Administration Device Approval Process
• New Device Approval Process
• New Device Approval
• Approval, New Device
• Approvals, New Device
• Device Approval, New
• Device Approvals, New
• New Device Approvals

Previous Indexing:

• Consumer Product Safety (1966-1994)

All MeSH Categories
Analytical, Diagnostic and Therapeutic Techniques and Equipment Category
Investigative Techniques
Evaluation Studies as Topic
Device Approval
Diagnostic Test Approval

All MeSH Categories
Health Care Category
Environment and Public Health
Public Health
Consumer Product Safety
Device Approval
Diagnostic Test Approval