PubMed

Integrated Devices: A New Regulatory Pathway to Promote Revolutionary Innovation.

PMID: 38253988 · 2024-01-22

T, e, d, , C, h, o, ;, , V, r, u, s, h, a, b, , G, o, w, d, a, ;, , H, e, n, n, i, n, g, , S, c, h, u, l, z, r, i, n, n, e, ;, , B, r, i, a, n, , J, , M, i, l, l, e, r

JournalThe Milbank quarterly

Year2024-01-22

PMID38253988

Abstract

Policy Points Current medical device regulatory frameworks date back half a century and are ill suited for the next generation of medical devices that involve a significant software component. Existing Food and Drug Administration efforts are insufficient because of a lack of statutory authority, whereas international examples offer lessons for improving and harmonizing domestic medical device regulatory policy. A voluntary alternative pathway built upon two-stage review with individual componen

Official Source

View on PubMed →

Data sourced from PubMed / NCBI. For the full text and most current information, always refer to the official record.