Estimated Cost of Developing a Therapeutic Complex Medical Device in the US-Reference-Cited by-同舟云学术

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Estimated Cost of Developing a Therapeutic Complex Medical Device in the US

Published:2022-09-14 Issue:9 Volume:5 Page:e2231609
ISSN:2574-3805
Container-title:JAMA Network Open
language:en
Short-container-title:JAMA Netw Open

Author:

Sertkaya Aylin¹,DeVries Rebecca¹,Jessup Amber²³⁴,Beleche Trinidad³⁴

Affiliation:

1. Eastern Research Group Inc, Lexington, Massachusetts

2. US Department of Health and Human Services, Office of Inspector General, Washington, DC

3. US Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Washington, DC

4. US Department of Health and Human Services, Office of Science and Data Policy, Washington, DC

Publisher

American Medical Association (AMA)

Subject

General Medicine

Link

https://jamanetwork.com/journals/jamanetworkopen/articlepdf/2796179/sertkaya_2022_oi_220893_1662133907.7801.pdf

Reference18 articles.

1. Innovation in the pharmaceutical industry: New estimates of R&D costs.;DiMasi;J Health Econ,2016

2. Estimated research and development investment needed to bring a new medicine to market, 2009-2018.;Wouters;JAMA,2020

3. Risk of recall among medical devices undergoing US Food and Drug Administration 510(k) clearance and premarket approval, 2008-2017.;Dubin;JAMA Netw Open,2021

4. 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.;Rathi;JAMA,2015

5. Characteristics of pivotal trials and FDA review of innovative devices.;Rising;PLoS One,2015

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