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

Detalles Bibliográficos
Autores principales: Mooghali, Maryam, Rathi, Vinay K, Kadakia, Kushal T, Ross, Joseph S, Dhruva, Sanket S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Analysis
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10687393/
https://www.ncbi.nlm.nih.gov/pubmed/38033980
http://dx.doi.org/10.1136/bmjsit-2023-000186
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author Mooghali, Maryam
Rathi, Vinay K
Kadakia, Kushal T
Ross, Joseph S
Dhruva, Sanket S
author_facet Mooghali, Maryam
Rathi, Vinay K
Kadakia, Kushal T
Ross, Joseph S
Dhruva, Sanket S
author_sort Mooghali, Maryam
collection PubMed
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spelling pubmed-106873932023-11-30 Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative Mooghali, Maryam Rathi, Vinay K Kadakia, Kushal T Ross, Joseph S Dhruva, Sanket S BMJ Surg Interv Health Technol Analysis BMJ Publishing Group 2023-09-28 /pmc/articles/PMC10687393/ /pubmed/38033980 http://dx.doi.org/10.1136/bmjsit-2023-000186 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Analysis
Mooghali, Maryam
Rathi, Vinay K
Kadakia, Kushal T
Ross, Joseph S
Dhruva, Sanket S
Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative
title Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative
title_full Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative
title_fullStr Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative
title_full_unstemmed Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative
title_short Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative
title_sort medical device risk (re)classification: lessons from the fda’s 515 program initiative
topic Analysis
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10687393/
https://www.ncbi.nlm.nih.gov/pubmed/38033980
http://dx.doi.org/10.1136/bmjsit-2023-000186
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