479. 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.
作者: Vinay K Rathi.;Harlan M Krumholz.;Frederick A Masoudi.;Joseph S Ross.
来源: JAMA. 2015年314卷6期604-12页
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.
480. Association Between Intermittent Hypoxemia or Bradycardia and Late Death or Disability in Extremely Preterm Infants.
作者: Christian F Poets.;Robin S Roberts.;Barbara Schmidt.;Robin K Whyte.;Elizabeth V Asztalos.;David Bader.;Aida Bairam.;Diane Moddemann.;Abraham Peliowski.;Yacov Rabi.;Alfonso Solimano.;Harvey Nelson.; .
来源: JAMA. 2015年314卷6期595-603页
Extremely preterm infants may experience intermittent hypoxemia or bradycardia for many weeks after birth. The prognosis of these events is uncertain.
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