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Home » FDA Issues Draft Guidance on Vitamin B7 Testing in IVDs

FDA Issues Draft Guidance on Vitamin B7 Testing in IVDs

FDA_Logo_Blue_2016.gif
June 13, 2019

The FDA released draft guidance on testing for biotin (vitamin B7) interference in in vitro diagnostics and devices used in donor screening.

The agency said it has become aware of potential biotin interference with IVDs that use biotin/avidin interactions as part of the device technology. Biotin in patient samples can cause falsely high or falsely low results, depending on the test.

The draft spells out how the agency would like the testing be performed and how the results of the testing should be communicated to end users, including clinical laboratories and clinicians. The agency wants manufacturers of currently marketed devices to consider the recommendations.

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
    • New Menu Placeholder NavLin
    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