FDA Regulation and Approval of Medical Devices: 1976-2020.
PMID: 34342614 ·
J, o, n, a, t, h, a, n, , J, , D, a, r, r, o, w, ;, , J, e, r, r, y, , A, v, o, r, n, ;, , A, a, r, o, n, , S, , K, e, s, s, e, l, h, e, i, m
Anzeige
Zusammenfassung
US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation. To review the development of laws and standards affecting the evaluation and oversight of medical d
Anzeige
Offizielle Quelle
Auf PubMed ansehen →Daten aus PubMed / NCBI. Den Volltext und die aktuellsten Informationen finden Sie stets im offiziellen Eintrag.