Modernizing the FDA's 510(k) Pathway

N Engl J Med. 2019 Nov 14;381(20):1891-1893. doi: 10.1056/NEJMp1908654. Epub 2019 Oct 23.
No abstract available

MeSH terms

  • Device Approval* / legislation & jurisprudence
  • United States
  • United States Food and Drug Administration*