federal_register: 2022-11122
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022-11122 | Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability | Notice | The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard (Broad Institute) for the CRSP SARS- CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay. FDA revoked this Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document. | 2022-05-24 | 2022 | 5 | https://www.federalregister.gov/documents/2022/05/24/2022-11122/revocation-of-authorization-of-emergency-use-of-an-in-vitro-diagnostic-device-for-detection-andor | https://www.govinfo.gov/content/pkg/FR-2022-05-24/pdf/2022-11122.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard (Broad Institute) for... |