federal_register: 2015-31407

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2015-31407 Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices." This leapfrog guidance document was developed to notify manufacturers of the recommended non-clinical and clinical studies to support a premarket approval application (PMA) for implantable MIGS devices. 2015-12-15 2015 12 https://www.federalregister.gov/documents/2015/12/15/2015-31407/premarket-studies-of-implantable-minimally-invasive-glaucoma-surgical-devices-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2015-12-15/pdf/2015-31407.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices." This leapfrog guidance document was developed to notify...

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