Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance—Reply
Author:
Affiliation:
1. Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, Massachusetts
2. Carlson School of Management, University of Minnesota, Minneapolis
3. Harvard Business School, Harvard University, Boston, Massachusetts
Publisher
American Medical Association (AMA)
Subject
General Medicine
Link
https://jamanetwork.com/journals/jama/articlepdf/2804609/jama_everhart_2023_lr_230018_1682951022.78612.pdf
Reference5 articles.
1. Association between regulatory submission characteristics and recalls of medical devices receiving 510(k) clearance.;Everhart;JAMA,2023
2. The Philips Respironics recall of ventilators and positive airway pressure machines—breakdowns in medical device surveillance.;Kadakia;JAMA Intern Med,2023
3. Adding device identifiers to claims forms—a key step to advance medical device safety.;Kadakia;BMJ,2023
4. Robles? O. Mapping the predicate chain for medical device approval. Published April 20, 2021. Accessed February 21, 2023. https://www.law360.com/articles/1377073/mapping-the-predicate-chain-for-medical-device-approval
5. Zhu? Y, Everhart? A, Karaca-Mandic? P, Sen? S. Using NLP to extract predicate history from medical device approvals. Published December 2, 2020. Accessed February 22, 2023. https://aisel.aisnet.org/icis2020/is_health/is_health/3
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