We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
    • Webinar Recordings
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Proposal Would Combine FDA Regs for IVDs, Lab-Developed Tests

Proposal Would Combine FDA Regs for IVDs, Lab-Developed Tests

April 5, 2017

A legislative discussion draft being floated in Congress would require the FDA to develop one set of regulations governing both in vitro diagnostics (IVDs) and laboratory-developed tests (LDTs) — to create a more predictable and timely path to market.

Currently, the FDA regulates IVDs but does not actively regulate LDTs. The Diagnostic Accuracy and Innovation Act, which is circulating as a discussion draft, would create a new category of products called in vitro clinical tests (IVCTs) that comprised both IVDs and LDTs and would be regulated separately from devices, drugs, and biologics.

The discussion draft would establish FDA jurisdiction over IVCT development and manufacturing while maintaining Centers for Medicare and Medicaid Services’ (CMS) oversight of laboratory operations. It also would establish a regulatory structure for IVCTs that addresses risk classification, premarket requirements, modifications, quality, post-market monitoring, and innovation.

Cosponsors Reps. Larry Bucshon (R-Ind.) and Diana DeGette (D-Colo.) are inviting comments on the draft by April 7. They plan to formally introduce the measure after reviewing the comments, a spokesman for Bucshon said.

View today's stories

Devices Regulatory Affairs

    Upcoming Events

    • 05Dec

      Thriving in Clinical Research – Overcoming Common Challenges as a Site: Part 3 – Site Resourcing

    • 07Dec

      Proactive Supplier Management Using Quality Agreements

    • 13Dec

      FDA Inspection Overhaul: How Things Have Changed in 2023

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • FDA, FTC and DOJ Enforcement of Medical Device Regulations

      FDA, FTC and DOJ Enforcement of Medical Device Regulations

    • Using Real-World Evidence in Drug and Device Submissions

      Using Real-World Evidence in Drug and Device Submissions

    Featured Stories

    • T-cell Malignancy From CAR-T Cell Immunotherapies Gets FDA Investigation

    • Vivos Sleep Apnea Oral Device Gets FDA Nod While Philips Wrestles With Yet Another CPAP Safety Issue

    • Novo Nordisk Battles Wegovy/Ozempic Pretenders and Faces Mounjaro’s Superior Study Results

    • Social, Emotional Risks Associated With Multi-Cancer Screening Discussed by Adcomm

    The Revised ICH E8: A Guide to New Clinical Trial Requirements

    Learn More
    • Drug Products
      • Quality
      • Regulatory Affairs
      • GMPs
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Device Products
      • Quality
      • Regulatory Affairs
      • QSR
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Clinical Products
      • Trial Design
      • Data Integrity
      • GCP
      • Inspections and Audits
      • Transparency
    • Privacy Policy
    • Do Not Sell or Share My Data
    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing