federal_register: 2014-23596

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
2014-23596 Framework for Regulatory Oversight of Laboratory Developed Tests; Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)." This document describes a risk-based framework for addressing the regulatory oversight of a subset of in vitro diagnostic devices (IVDs) referred to as laboratory developed tests (LDTs), which are intended for clinical use and designed, manufactured and used within a single laboratory. This document describes FDA's priorities for enforcing pre- and post- market requirements for LDTs, and the process by which FDA intends to phase in enforcement of FDA regulatory requirements for LDTs over time. This draft guidance is not final, nor is it in effect at this time. 2014-10-03 2014 10 https://www.federalregister.gov/documents/2014/10/03/2014-23596/framework-for-regulatory-oversight-of-laboratory-developed-tests-draft-guidance-for-industry-food https://www.govinfo.gov/content/pkg/FR-2014-10-03/pdf/2014-23596.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)." This document describes a risk-based framework for addressing the regulatory...  

Links from other tables