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federal_register: 2012-22518

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2012-22518 Food and Drug Administration/American Glaucoma Society Workshop on the Validity, Reliability, and Usability of Glaucoma Imaging Devices Notice The Food and Drug Administration (FDA) is announcing a public workshop entitled "FDA/American Glaucoma Society (AGS) Workshop on the Validity, Reliability, and Usability of Glaucoma Imaging Devices." FDA is co-sponsoring the workshop together with the AGS, a nonprofit organization that supports glaucoma specialists and scientists through the advancement of education and research. The purpose of this public workshop is to provide a forum for discussing the validity, reliability, and usability of glaucoma imaging devices. The primary topic to be discussed relates to imaging of the posterior segment of the eye (e.g., retinal nerve fiber layer, optic nerve head, ganglion cell layer) using Optical Coherence Tomography (OCT, time domain and spectral domain), with particular emphasis on normative databases and the diagnostic performance of OCT for therapeutic glaucoma products (regulatory considerations) and clinical decision making (clinical practice considerations). 2012-09-13 2012 9 https://www.federalregister.gov/documents/2012/09/13/2012-22518/food-and-drug-administrationamerican-glaucoma-society-workshop-on-the-validity-reliability-and https://www.govinfo.gov/content/pkg/FR-2012-09-13/pdf/2012-22518.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing a public workshop entitled "FDA/American Glaucoma Society (AGS) Workshop on the Validity, Reliability, and Usability of Glaucoma Imaging Devices." FDA is co-sponsoring the workshop together with the...  

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