federal_register: 2011-31214

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-31214 Draft Guidance for Industry and Food and Drug Administration Staff; the Content of Investigational Device Exemption and Premarket Approval Applications for Artificial Pancreas Device Systems; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled "Draft Guidance for Industry and FDA Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems." This draft guidance document provides industry and the Agency staff with guidelines for developing premarket submissions for artificial pancreas device systems, in particular, the Control-to-Range (CTR) and Control-to-Target (CTT) device systems. This draft guidance is not final nor is it in effect at this time. 2011-12-06 2011 12 https://www.federalregister.gov/documents/2011/12/06/2011-31214/draft-guidance-for-industry-and-food-and-drug-administration-staff-the-content-of-investigational https://www.govinfo.gov/content/pkg/FR-2011-12-06/pdf/2011-31214.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled "Draft Guidance for Industry and FDA Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications...

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