PubMed

Sensitivity of 510(k) medical device filings to government shutdowns: a brief communication.

PMID：42686814 · 2026-09-02

K, a, r, l, , L, , S, c, h, u, m, a, c, h, e, r, ;, , S, i, n, d, u, r, a, , P, e, n, u, b, a, r, t, h, i, ;, , P, r, a, s, h, a, n, t, h, , A, s, u, r, i

期刊npj health systems

年份2026-09-02

PMID42686814

摘要

Government shutdowns may impose indirect regulatory costs on medical device manufacturers by disrupting FDA review processes. This study examines changes in 510(k) review durations surrounding the 2013 and 2018 U.S. government shutdowns. We identify significant increases in post-shutdown review times and distinct timing-dependent effects across shutdowns, highlighting the sensitivity of regulatory review timelines to operational disruptions and suggest that even partial shutdowns impede medical

官方来源

在 PubMed 上查看 →

数据来自 PubMed / NCBI。有关全文和最新信息，请始终参阅官方记录。