Harvard Catalyst Profiles

Contact, publication, and social network information about Harvard faculty and fellows.

Vinay Kumar Rathi, M.D.


This page shows the publications Vinay Rathi has written about Product Surveillance, Postmarketing.
  1. Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019. JAMA Intern Med. 2020 12 01; 180(12):1701-1703.
    View in: PubMed
    Score: 0.611
  2. Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011. JAMA Netw Open. 2020 08 03; 3(8):e2014496.
    View in: PubMed
    Score: 0.598
  3. US Food and Drug Administration Clearance of Moderate-Risk Otolaryngologic Devices via the 510(k) Process, 1997-2016. Otolaryngol Head Neck Surg. 2017 10; 157(4):608-617.
    View in: PubMed
    Score: 0.486
  4. Postmarket Modifications of High-Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration. Otolaryngol Head Neck Surg. 2015 Sep; 153(3):400-8.
    View in: PubMed
    Score: 0.418
  5. Early experience with the FDA's Breakthrough Devices program. Nat Biotechnol. 2020 08; 38(8):933-938.
    View in: PubMed
    Score: 0.149
  6. Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979-2015. Ophthalmology. 2017 08; 124(8):1237-1246.
    View in: PubMed
    Score: 0.119
  7. How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval? Clin Orthop Relat Res. 2016 Apr; 474(4):1053-68.
    View in: PubMed
    Score: 0.108
  8. 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):604-12.
    View in: PubMed
    Score: 0.106
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Funded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number UL1TR002541.