federal_register: 2014-23586

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
2014-23586 Food and Drug Administration Notification and Medical Device Reporting for Laboratory Developed Tests; Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)." This draft guidance document is intended to describe the process for clinical laboratories to notify FDA of the laboratory developed tests (LDTs) they manufacture as well as to describe the Medical Device Reporting (MDR) requirements for clinical laboratories manufacturing LDTs. LDTs are those in vitro diagnostic devices that are intended for clinical use and designed, manufactured, and used within a single laboratory. This draft guidance is not final nor is it in effect at this time. 2014-10-03 2014 10 https://www.federalregister.gov/documents/2014/10/03/2014-23586/food-and-drug-administration-notification-and-medical-device-reporting-for-laboratory-developed https://www.govinfo.gov/content/pkg/FR-2014-10-03/pdf/2014-23586.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)." This draft guidance document is intended to describe the process...  

Links from other tables