4.7 Letter

Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011

Journal

JAMA NETWORK OPEN
Volume 3, Issue 8, Pages -

Publisher

AMER MEDICAL ASSOC
DOI: 10.1001/jamanetworkopen.2020.14496

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Funding

  1. NCATS NIH HHS [UL1 TR001863] Funding Source: Medline

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This cross-sectional study provides a 5-year update on the status and availability of postmarket evidence for high-risk medical devices that received FDA premarket approval in 2010 and 2011.

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