Review

Approval of high-risk medical devices in the US: implications for clinical cardiology.

Curr Cardiol Rep. 2014 Jan 1; 16 (6): 489.
Article

Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices, 2000-2014.

Otolaryngol Head Neck Surg. 2017 Feb 1; 156 (2): 285-288.
Article

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.

JAMA. 2015 Aug 11; 314 (6): 604612604-12.