Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011 | Zendy

Vinay K. Rathi | Zendy; Harlan M. Krumholz | Zendy; Frederick A. Masoudi | Zendy; Joseph S. Ross | Zendy

Open Access

Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011

Author(s) -

Vinay K. Rathi,

Harlan M. Krumholz,

Frederick A. Masoudi,

Joseph S. Ross

Publication year - 2015

Publication title -

jama

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 4.688

H-Index - 680

eISSN - 1538-3598

pISSN - 0098-7484

DOI - 10.1001/jama.2015.8761

Subject(s) - medicine , food and drug administration , medical device , medline , pharmacology , political science , law , biomedical engineering

The US Food and Drug Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle.

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