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 In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled ``Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Document
Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period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...
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83 FR 3740
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“Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period,” thefederalregister.org (January 26, 2018), https://thefederalregister.org/documents/2018-01350/recommendations-for-dual-510-k-and-clinical-laboratory-improvement-amendments-waiver-by-application-studies-draft-guidan.