Modernizing the FDA’s 510(k) Pathway

More than 90% of FDA-reviewed devices enter the market by means of the 510(k) pathway. In September 2019, the FDA finalized reforms to the pathway. But further steps could better support protection of patients and public health.

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Bibliographische Detailangaben
Veröffentlicht in:	The New England journal of medicine 2019-11, Vol.381 (20), p.1891-1893
Hauptverfasser:	Rathi, Vinay K, Ross, Joseph S
Format:	Artikel
Sprache:	eng
Schlagworte:	Manufacturers Manufacturing Market entry Medical equipment Medical technology Public health
Online-Zugang:	Volltext
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Beschreibung
Zusammenfassung:	More than 90% of FDA-reviewed devices enter the market by means of the 510(k) pathway. In September 2019, the FDA finalized reforms to the pathway. But further steps could better support protection of patients and public health.
ISSN:	0028-4793 1533-4406
DOI:	10.1056/NEJMp1908654