federal_register: 2020-01342
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020-01342 | Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use-Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use--Premarket Notification (510(k)) Submissions." FDA has developed this draft guidance document to assist in the preparation of premarket notification submissions (510(k)) for arthroscopy pump tubing sets intended for multiple patient use. This draft guidance outlines the device design considerations, risk mitigation strategies, and testing recommendations for arthroscopy pump tubing sets intended for multiple patient use. This draft guidance document also clarifies the terminology used to describe arthroscopy pump tubing sets intended for multiple patient use. This draft guidance is not final nor is it in effect at this time. | 2020-01-28 | 2020 | 1 | https://www.federalregister.gov/documents/2020/01/28/2020-01342/arthroscopy-pump-tubing-sets-intended-for-multiple-patient-use-premarket-notification-510k | https://www.govinfo.gov/content/pkg/FR-2020-01-28/pdf/2020-01342.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Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use--Premarket Notification (510(k)) Submissions." FDA has developed this draft... |