federal_register: 2017-25775

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2017-25775 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Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices." FDA has developed this draft guidance to implement a section of the 21st Century Cures Act (Cures Act) that requires FDA to revise "V. Demonstrating Insignificant Risk of an Erroneous Result-- Accuracy" of the guidance "Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices" ("2008 CLIA Waiver Guidance") that was issued on January 30, 2008. This draft guidance updates FDA's thinking regarding the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy. This draft guidance is not final nor is it in effect at this time. 2017-11-29 2017 11 https://www.federalregister.gov/documents/2017/11/29/2017-25775/select-updates-for-recommendations-for-clinical-laboratory-improvement-amendments-of-1988-waiver https://www.govinfo.gov/content/pkg/FR-2017-11-29/pdf/2017-25775.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and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In...  

Links from other tables