federal_register: 2014-17666

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2014-17666 The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications; Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]." This guidance document describes FDA's current review practices for premarket notification (510(k)) submissions by describing in greater detail the regulatory framework, policies, and practices underlying FDA's review of traditional 510(k) submissions. This guidance document does not address the special and abbreviated 510(k) programs. FDA intends to finalize those sections separately. 2014-07-28 2014 7 https://www.federalregister.gov/documents/2014/07/28/2014-17666/the-510k-program-evaluating-substantial-equivalence-in-premarket-notifications-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2014-07-28/pdf/2014-17666.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]." This guidance document describes FDA's current review practices...  

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