E. National Academies of Sciences, and Medicine, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press, 2011.
S. S. Dhruva et al., “Physicians’ Perspectives On FDA Regulation Of Drugs And Medical Devices: A National Survey,” Health Aff (Millwood), vol. 43, no. 1, pp. 27–35, Jan 2024, https://doi.org/10.1377/hlthaff.2023.00466.
C. H. Krissman. “Dalkon Shield.” Encyclopedia Britannica. https://www.britannica.com/science/Dalkon-Shield (accessed September 5, 2024).
D. Hubacher and D. Cheng, “Intrauterine devices and reproductive health: American women in feast and famine,” Contraception, vol. 69, no. 6, pp. 437– 46, Jun 2004, https://doi.org/10.1016/j.contraception.2004.01.009.
H. J. Davis, “The shield intrauterine device. A superior modern contraceptive,” Am J Obstet Gynecol, vol. 106, no. 3, pp. 455-6, Feb 1 1970, https://doi.org/10.1016/0002-9378(70)90375-3.
Medical Device Amendments of 1976, Public Law 94–295, 1976.
“Standards.” ISO. https://www.iso.org/standards.html (accessed 8/30, 2023).
“Who we are.” IEC. https://www.iec.ch/who-we-are (accessed 8/30, 2024).
J. Okun-Kozlowicki, “Standards and Regulations: Measuring the Link to Goods Trade,” International Trade Administration, June 2016 2016. [Online]. Available: https://legacy.trade.gov/td/osip/documents/osip_standards_trade_full_paper.pdf
K. Imagawa, Y. Mizukami, and S. Miyazaki, “Regulatory convergence of medical devices: a case study using ISO and IEC standards,” Expert Rev Med Devices, vol. 15, no. 7, pp. 497–504, Jul 2018, https://doi.org/10.1080/17434440.2018.1492376.
Article CAS PubMed Google Scholar
K. Saito, Hishiki, Y., & Takahashi, H., “Validation of the omron hbp-9031c blood pressure monitor for clinics and hospitals according to the ansi/aami/iso 81060-2:2013 protoco,” Annals of Clinical Hypertension, vol. 3, no. 1, pp. 43–48, 2019, https://doi.org/10.29328/journal.ach.1001018.
G. S. Stergiou et al., “A Universal Standard for the Validation of Blood Pressure Measuring Devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement,” Hypertension, vol. 71, no. 3, pp. 368–374, Mar 2018, https://doi.org/10.1161/HYPERTENSIONAHA.117.10237.
C. Ho, D. Jensen, F. Lacy, N. Muni, S. Reilly, and E. Mallis, “Use of standards in the review of medical devices,” J Electrocardiol, vol. 38, no. 4 Suppl, pp. 171-4, Oct 2005, https://doi.org/10.1016/j.jelectrocard.2005.06.030.
P. McAllister and J. Jeswiet, “Medical device regulation for manufacturers,” Proc Inst Mech Eng H, vol. 217, no. 6, pp. 459– 67, 2003, https://doi.org/10.1243/09544110360729090.
R. E. Galgon, “Understanding medical device regulation,” Curr Opin Anaesthesiol, vol. 29, no. 6, pp. 703–710, Dec 2016, https://doi.org/10.1097/ACO.0000000000000391.
“Overview of Device Regulation.” FDA. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation (accessed 8/30, 2024).
U. S. F. a. D. A. (FDA). “510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (510(k)).” https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k (accessed September 1, 2024).
U. S. F. a. D. A. (FDA). “PMA Approvals.” https://www.fda.gov/medical-devices/device-approvals-and-clearances/pma-approvals (accessed September 1, 2024).
J. J. Darrow, J. Avorn, and A. S. Kesselheim, “FDA Regulation and Approval of Medical Devices: 1976–2020,” JAMA, vol. 326, no. 5, pp. 420–432, Aug 3 2021, https://doi.org/10.1001/jama.2021.11171.
B. M. Ardaugh, S. E. Graves, and R. F. Redberg, “The 510(k) ancestry of a metal-on-metal hip implant,” N Engl J Med, vol. 368, no. 2, pp. 97–100, Jan 10 2013, https://doi.org/10.1056/NEJMp1211581.
Article CAS PubMed Google Scholar
G. S. Matharu, A. Eskelinen, A. Judge, H. G. Pandit, and D. W. Murray, “Revision surgery of metal-on-metal hip arthroplasties for adverse reactions to metal debris,” Acta Orthop, vol. 89, no. 3, pp. 278–288, Jun 2018, https://doi.org/10.1080/17453674.2018.1440455.
Article PubMed PubMed Central Google Scholar
U. S. F. a. D. Administratin, “Class 2 Device Recall DEPUY ASR 300 ACETABULAR CUP SYSTEM,” 2011. [Online]. Available: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96129.
D. B. Kramer and A. S. Kesselheim, “The Watchman saga–closure at last?,” N Engl J Med, vol. 372, no. 11, pp. 994–5, Mar 12 2015, https://doi.org/10.1056/NEJMp1415738.
留言 (0)