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. 2023 Feb 8;5(1):e000152.
doi: 10.1136/bmjsit-2022-000152. eCollection 2023.

Market competition among manufacturers of novel high-risk therapeutic devices receiving FDA premarket approval between 2001 and 2018

Vinay K Rathi  1 , James L Johnston  2 , Sanket Dhruva  3   4 , Joseph Ross  5   6   7   8
Affiliations

Market competition among manufacturers of novel high-risk therapeutic devices receiving FDA premarket approval between 2001 and 2018

Vinay K Rathi et al. BMJ Surg Interv Health Technol. .
No abstract available

Keywords: Device Approval; Medical Device Legislation.

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Conflict of interest statement

Competing interests: VKR reports prior employment by F-Prime Capital to identify and qualify investment opportunities in early stage life-sciences companies.

References

    1. Rathi VK, Krumholz HM, Masoudi FA, et al. . 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;314:604–12. 10.1001/jama.2015.8761 - DOI - PubMed
    1. Medicare Payment Advisory Commission . Report to the congress: medicare and the health care delivery system. 2017: 207–42. Available: http://www.medpac.gov/docs/default-source/reports/jun17_ch7.pdf?sfvrsn=0
    1. Johnston JL, Dhruva SS, Ross JS, et al. . 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;180:1701–3. 10.1001/jamainternmed.2020.3214 - DOI - PMC - PubMed
    1. U.S. Food and Drug Administration . Premarket approval (PMA) database. 2022. Available: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm
    1. DiMasi JA, Chakravarthy R. Competitive development in pharmacologic classes: market entry and the timing of development. Clin Pharmacol Ther 2016;100:754–60. 10.1002/cpt.502 - DOI - PubMed

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