federal_register: 2014-29832

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2014-29832 Transfer of a Premarket Notification (510(k)) Clearance-Questions and Answers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Transfer of a Premarket Notification (510(k)) Clearance--Questions and Answers." The purpose of the draft guidance is to provide information on how to notify FDA of the transfer of a premarket notification clearance from one holder to another, and the procedures FDA and industry should use to ensure public information in FDA's databases about the current 510(k) holder for a specific device(s) is accurate and up-to-date. This draft guidance is not final nor is it in effect at this time. 2014-12-22 2014 12 https://www.federalregister.gov/documents/2014/12/22/2014-29832/transfer-of-a-premarket-notification-510k-clearance-questions-and-answers-draft-guidance-for https://www.govinfo.gov/content/pkg/FR-2014-12-22/pdf/2014-29832.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Transfer of a Premarket Notification (510(k)) Clearance--Questions and Answers." The purpose of the draft guidance is to provide information on how to...  

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