FDA Surveillance Project

Optimizing Medical Device Post-Market Surveillance for Public Value

Related Press and Publications (not all of which were supported by FDA Cooperative Agreement)


Samuel AM, Rathi VK, Grauer JN, Ross JS. How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval? Clin Orthop Relat Res. 2016; 474(4):1053-1068.


Phillips AT, Rathi VK, Ross JS. Publication of Clinical Studies Supporting FDA Premarket Approval for High-Risk Cardiovascular Devices Between 2011 and 2013: A Cross-sectional Study. JAMA. 2016; 176(4):551-552.


Rathi VK, Kesselheim AS, Ross JS. The US Food and Drug Administration 515 Program Initiative Addressing the Evidence Gap for Widely Used, High-Risk Cardiovascular Devices? JAMA Cardiol. Published online March 09, 2016. doi:10.1001/jamacardio.2016.0002.


Bikdeli B, Wang Y, Minges KE, Desai NR, Kim N, Desai MM, Spertus JA, Masoudi FA, Nallamothu BK, Goldhaber SZ, Krumholz HM. Vena Caval Filter Utilization and Outcomes in Pulmonary Embolism: Medicare Hospitalizations From 1999 to 2010. J Am Coll Cardiol. 2016; 67(9):1027-1035.


Ross JS, Kesselheim AS. FDA Policy and Cardiovascular Medicine. Circulation. 2015; 132(12):1136-1145.


Rathi VK, Ross JS, Samuel AM, Mehra S. Postmarket Modifications of High-Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration. Otolaryngol Head Neck Surg. 2015; 153(3):400-408.


Rathi VK, Krumholz HM, Masoudi FA, Ross JS. 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; 314(6):604-612.


Ross JS, Blount KL, Ritchie JD, Hodshon B, Krumholz HM. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey. Medical Devices: Evidence and Research. 2015;8:241-249.


Lampropulos JF, Kim N, Wang Y, et al. Trends in left ventricular assist device use and outcomes among Medicare beneficiaries, 2004–2011. Open Heart. 2014; 1(1):e000109. doi:10.1136/openhrt-2014-000109.


Gupta A, Desai MM, Kim N, Bulsara KR, Wang Y, Krumholz HM. Trends in intracranial stenting among medicare beneficiaries in the United States, 2006-2010. J Am Heart Assoc. 2013; 2(2):e000084. doi: 10.1161/JAHA.113.000084.


FDA supports Yale/Medtronic medical device surveillance initiative
Yale News, January 9, 2013

Dr. Harlan M. Krumholz FDA Think Tank on Surveillance Planning

Dr. Harlan M. Krumholz FDA Think Tank on Surveillance Planning

Dr. Harlan M. Krumholz FDA Think Tank on Surveillance Planning