federal_register: 2011-32437

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-32437 Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices." This document describes FDA's intent with regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology devices under the regulations. 2011-12-20 2011 12 https://www.federalregister.gov/documents/2011/12/20/2011-32437/guidance-for-industry-and-food-and-drug-administration-staff-enforcement-policy-for-premarket https://www.govinfo.gov/content/pkg/FR-2011-12-20/pdf/2011-32437.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices." This document describes FDA's intent with...

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