federal_register: 2020-03859
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 | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020-03859 | Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Recommendations for Dual 510(k) and CLIA Waiver by Application Studies." It describes study designs for generating data that may support both 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver. Use of the Dual 510(k) and CLIA Waiver by Application pathway is optional; however, FDA believes this pathway is in many instances the least burdensome and fastest approach for manufacturers to obtain a CLIA waiver at the same time as 510(k) clearance for new in vitro diagnostic (IVD) tests. FDA believes increased use of this pathway will speed up the process of bringing simple and accurate IVD tests to CLIA- waived settings, which will better serve patients and providers. | 2020-02-26 | 2020 | 2 | https://www.federalregister.gov/documents/2020/02/26/2020-03859/recommendations-for-dual-510k-and-clinical-laboratory-improvement-amendments-waiver-by-application | https://www.govinfo.gov/content/pkg/FR-2020-02-26/pdf/2020-03859.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 a final guidance entitled "Recommendations for Dual 510(k) and CLIA Waiver by Application Studies." It describes study designs for generating data that may support both... |