Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative

Author:

Mooghali MaryamORCID,Rathi Vinay KORCID,Kadakia Kushal T,Ross Joseph SORCID,Dhruva Sanket SORCID

Publisher

BMJ

Subject

Biomedical Engineering,Surgery

Reference20 articles.

1. U.S. Food and Drug Adminstration . Regulatory controls. 2018. Available: https://www.fda.gov/medical-devices/overview-device-regulation/regulatory-controls [Accessed 26 Jan 2023].

2. Institute of Medicine . Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press, 2011.

3. 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

4. U.S. Food and Drug Adminstration . Reclassification. 2021. Available: https://www.fda.gov/about-fda/cdrh-transparency/reclassification [Accessed 26 Jan 2023].

5. U.S. Food and Drug Administration . Making permanent regulatory flexibilities provided during the COVID-19 public health emergency by exempting certain medical devices from premarket notification requirements; withdrawal of proposed exemptions: Federal register. 2021. Available: https://www.federalregister.gov/documents/2021/04/16/2021-07760/making-permanent-regulatory-flexibilities-provided-during-the-covid-19-public-health-emergency-by [Accessed 26 Jan 2023].

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