Device Approval [schvalování záměrů]

topical
264
Terms

FDA proces schvalování zařízení
FDA schválení zařízení
FDA schvalování zařízení
postup schválení nového zařízení
schválení nového zařízení
schvalování zdravotnických postupů

 

Device Approval Process
Food and Drug Administration Device Approval
Food and Drug Administration Device Approval Process
New Device Approval
New Device Approval Process

Persistent link   https://www.medvik.cz/link/D018795
Definition

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.

Annotation
by a govt regulatory agency, not restricted to FDA
DUI
D018795 MeSH Browser
CUI
M0028140
Previous indexing
Consumer Product Safety (1966-1994)
History note
95
Public note
95

Allowable subheadings

LJ
legislation & jurisprudence 60
ST
standards 76

E Analytical, Diagnostic and Therapeutic Techniques and Equipment
E05 Investigative Techniques 209
E05.337 Evaluation Studies as Topic 1 231
E05.337.275 Device Approval 264
E05.337.275.500 Diagnostic Test Approval 3
E05.337.300 Drug Approval 1 769
E05.337.425 Drug Evaluation 5 293
E05.337.550 Drug Evaluation, Preclinical 552
E05.337.675 Feasibility Studies 225
E05.337.737 Pilot Projects 1 786
E05.337.800 Product Surveillance, Postmarketing 49
E05.337.820 Program Evaluation 300
E05.337.851 Reproducibility of Results 2 380
E05.337.925 Validation Studies as Topic 68

N Health Care
N06 Environment and Public Health 202
N06.850 Public Health 4 036
N06.850.210 Consumer Product Safety 151
N06.850.210.275 Device Approval 264
N06.850.210.275.500 Diagnostic Test Approval 3
N06.850.210.637 Product Recalls and Withdrawals 6

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