US Food and Drug Administration Regulatory Programs for Innovative Technologies
Author:
Affiliation:
1. Byers Eye Institute, Stanford, Palo Alto, California
2. Office of Product Evaluation and Quality, Office of Ophthalmic, Anesthesia, Respiratory and Ear, Nose, and Throat and Dental Devices, US Food and Drug Administration, Silver Spring, Maryland
Publisher
American Medical Association (AMA)
Subject
Ophthalmology
Link
https://jamanetwork.com/journals/jamaophthalmology/articlepdf/2751381/jamaophthalmology_brodie_2019_vp_190003.pdf
Reference5 articles.
1. The US Food and Drug Administration’s new regulatory toolkit to bring medical device innovation back to the United States.;Eydelman;JAMA Ophthalmol,2016
2. Incidence and prevalence of uveitis: results from the Pacific Ocular Inflammation Study.;Acharya;JAMA Ophthalmol,2013
3. Clinical characteristics and current therapies for inherited retinal degenerations.;Sahel;Cold Spring Harb Perspect Med,2014
4. United States Food and Drug Administration. Guidance documents (medical devices and radiation-emitting products). https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. Accessed May 14, 2019.
5. US Congress. 21st Century Cures Act. https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf. Accessed March 30, 2019.
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2. FDA Facilitating Innovation of Ophthalmic Devices While Balancing the Need for Safety and Effectiveness;JAMA Ophthalmology;2022-04-01
3. Ethics of Artificial Intelligence in Medicine and Ophthalmology;Asia-Pacific Journal of Ophthalmology;2021-05
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