FDA Facilitating Innovation of Ophthalmic Devices While Balancing the Need for Safety and Effectiveness
Author:
Affiliation:
1. Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland
Publisher
American Medical Association (AMA)
Subject
Ophthalmology
Link
https://jamanetwork.com/journals/jamaophthalmology/articlepdf/2789794/jamaophthalmology_nguyen_2022_vp_220003_1649949487.42083.pdf
Reference10 articles.
1. FDA regulation and approval of medical devices: 1976-2020.;Darrow;JAMA,2021
2. US Food and Drug Administration regulatory programs for innovative technologies.;Brodie;JAMA Ophthalmol,2019
3. Special report: American Academy of Ophthalmology Task Force Consensus Statement for extended depth-of-focus intraocular lenses.;MacRae;Ophthalmology,2017
4. US Food and Drug Administration. Press announcements. Accessed January 10, 2022. https://www.fda.gov/news-events/fda-newsroom/press-announcements
5. US Food and Drug Administration. Workshops & conferences (medical devices). Accessed January 10, 2022. http://wayback.archive-it.org/7993/20180124213834/https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm
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