federal_register: 2017-27132
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2017-27132 | Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices." FDA is issuing this draft guidance document to update and clarify the policy for a manufacturer's application of an assay that was previously cleared for use based on performance characteristics with a specified instrument, to an additional instrument that was previously cleared or that is a member of an instrument family from which another member has been previously cleared. When finalized, this document will supersede "Replacement Reagent and Instrument Family Policy," issued on December 11, 2003. This draft guidance is not final nor is it in effect at this time. | 2017-12-18 | 2017 | 12 | https://www.federalregister.gov/documents/2017/12/18/2017-27132/replacement-reagent-and-instrument-family-policy-for-in-vitro-diagnostic-devices-draft-guidance-for | https://www.govinfo.gov/content/pkg/FR-2017-12-18/pdf/2017-27132.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices." FDA is issuing this draft guidance document to update and... |