federal_register: 2013-28084

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2013-28084 Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only." This guidance document is intended for manufacturers and distributors of "for research use only" (RUO) and "for investigational use only" (IUO) in vitro diagnostic (IVD) products and any other entities who label IVD products, as well as FDA staff. 2013-11-25 2013 11 https://www.federalregister.gov/documents/2013/11/25/2013-28084/distribution-of-in-vitro-diagnostic-products-labeled-for-research-use-only-or-investigational-use https://www.govinfo.gov/content/pkg/FR-2013-11-25/pdf/2013-28084.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 "Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only." This guidance document is intended for...

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