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 In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled ``Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for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.
Document
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Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period
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. I...
Legal Citation
Federal Register Citation
Use this for formal legal and research references to the published document.
83 FR 3739
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“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Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period,” thefederalregister.org (January 26, 2018), https://thefederalregister.org/documents/2018-01349/select-updates-for-recommendations-for-clinical-laboratory-improvement-amendments-of-1988-waiver-applications-for-manufa.