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federal_register: 2014-28267

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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
2014-28267 Infusion Pumps Total Product Life Cycle; Guidance for Industry and Food and Drug Administration Staff; Availability Notice Food and Drug Administration (FDA) is announcing the availability of the final guidance entitled, "Infusion Pumps Total Product Life Cycle; Guidance for Industry and FDA Staff." The recommendations in this guidance are intended to improve the safety and effectiveness of these devices. This guidance also describes considerations in preparing premarket submissions for infusion pumps and identifies device features that manufacturers should address throughout the total product life cycle. 2014-12-02 2014 12 https://www.federalregister.gov/documents/2014/12/02/2014-28267/infusion-pumps-total-product-life-cycle-guidance-for-industry-and-food-and-drug-administration-staff https://www.govinfo.gov/content/pkg/FR-2014-12-02/pdf/2014-28267.pdf Health and Human Services Department; Food and Drug Administration 221,199 Food and Drug Administration (FDA) is announcing the availability of the final guidance entitled, "Infusion Pumps Total Product Life Cycle; Guidance for Industry and FDA Staff." The recommendations in this guidance are intended to improve the safety...  

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