federal_register: 2018-01349

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2018-01349 Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period Notice The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of November 29, 2017. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled "Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. 2018-01-26 2018 1 https://www.federalregister.gov/documents/2018/01/26/2018-01349/select-updates-for-recommendations-for-clinical-laboratory-improvement-amendments-of-1988-waiver https://www.govinfo.gov/content/pkg/FR-2018-01-26/pdf/2018-01349.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of November 29, 2017. In the notice of availability, FDA requested comments on draft guidance for...  

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