{"database": "openregs", "table": "federal_register", "rows": [["2014-23586", "Food and Drug Administration Notification and Medical Device Reporting for Laboratory Developed Tests; Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories; Availability", "Notice", "The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled \"FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).\" This draft guidance document is intended to describe the process for clinical laboratories to notify FDA of the laboratory developed tests (LDTs) they manufacture as well as to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 This draft guidance is not final nor is it in effect at this time.", "2014-10-03", 2014, 10,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Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled \"FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).\" This draft guidance document is intended to describe the process...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url", "pdf_url", "agency_names", "agency_ids", "excerpts", "regulation_id_numbers"], "primary_keys": ["document_number"], "primary_key_values": ["2014-23586"], "units": {}, "query_ms": 0.3429169300943613, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}