federal_register: 2015-02722

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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
2015-02722 Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices." This leap frog 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. This draft guidance is not final nor is it in effect at this time. 2015-02-11 2015 2 https://www.federalregister.gov/documents/2015/02/11/2015-02722/premarket-studies-of-implantable-minimally-invasive-glaucoma-surgical-devices-draft-guidance-for https://www.govinfo.gov/content/pkg/FR-2015-02-11/pdf/2015-02722.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices." This leap frog guidance document was developed to notify...  

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