PubMed

Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices, 2000-2014.

PMID : 28093943 · 2017-01-17

V, i, n, a, y, , K, , R, a, t, h, i, ;, , B, o, , W, a, n, g, ;, , J, o, s, e, p, h, , S, , R, o, s, s, ;, , N, i, c, h, o, l, a, s, , S, , D, o, w, n, i, n, g, ;, , A, a, r, o, n, , S, , K, e, s, s, e, l, h, e, i, m, ;, , S, t, a, c, e, y, , T, , G, r, a, y

RevueOtolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery

Année2017-01-17

PMID28093943

Résumé

The US Food and Drug Administration (FDA) approves high-risk medical devices based on premarket pivotal clinical studies demonstrating reasonable assurance of safety and effectiveness and may require postapproval studies (PAS) to further inform benefit-risk assessment. We conducted a cross-sectional analysis using publicly available FDA documents to characterize industry-sponsored pivotal studies and PAS of high-risk devices used in the treatment of otolaryngologic diseases. Between 2000 and 201

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