federal_register: 2015-16011

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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
2015-16011 Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings." FDA is issuing this draft guidance to describe the Agency's premarket regulatory requirements and the performance testing needed to support liquid barrier claims for gowns intended for use in health care settings. This draft guidance is being issued in light of the public health importance of personal protective equipment in health care settings and the recognition that terminology used to describe gowns has evolved, including by industry, the standards community, and health care professionals. This draft guidance is not final nor is it in effect at this time. 2015-06-30 2015 6 https://www.federalregister.gov/documents/2015/06/30/2015-16011/premarket-notification-requirements-concerning-gowns-intended-for-use-in-health-care-settings-draft https://www.govinfo.gov/content/pkg/FR-2015-06-30/pdf/2015-16011.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings." FDA is issuing this draft guidance to describe the...  

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