federal_register: 2021-27823

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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
2021-27823 Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use--Premarket Notification (510(k)) Submissions." FDA has developed this guidance document to assist in the preparation of premarket notification submissions (510(k)) for arthroscopy pump tubing sets intended for multiple patient use. This guidance outlines the device design considerations, risk mitigation strategies, and testing recommendations for arthroscopy pump tubing sets intended for multiple patient use. This guidance also clarifies the terminology used to describe arthroscopy pump tubing sets intended for multiple patient use. 2021-12-23 2021 12 https://www.federalregister.gov/documents/2021/12/23/2021-27823/arthroscopy-pump-tubing-sets-intended-for-multiple-patient-use-premarket-notification-510k https://www.govinfo.gov/content/pkg/FR-2021-12-23/pdf/2021-27823.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use--Premarket Notification (510(k)) Submissions." FDA has developed this guidance...  

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