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.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Asked to Not Enforce UDI Deadline on Existing Ortho Devices

FDA Asked to Not Enforce UDI Deadline on Existing Ortho Devices

May 22, 2015

Orthopedic companies should be allowed to continue distributing devices that don’t bear unique device identifiers even after the FDA’s compliance deadline, Globus Medical says in a recent citizen’s petition to the agency.

The final rule gives devicemakers three years to use or relabel preexisting stock after UDIs are required for new devices. For Class III devices, that deadline falls in 2018; for Class II devices, it’s a year later. After that, the agency may take enforcement action against companies whose products don’t carry UDIs.

That’s unrealistic for orthopedic implants because of their distribution model, Globus Senior Group Manager Kelly Quick writes in the petition. Because patients have such varying implant needs, devicemakers commonly provide many choices for each surgery. Implants that aren’t used are put back into storage, she says, adding that implants are paid for only when they are used.

The upshot of this model is that many implants could remain in commercial distribution, unsold, for years past the UDI compliance date. The process of recalling devices already shipped to healthcare facilities to apply UDI markings would be expensive, technically difficult and offer few benefits in terms of product traceability, Quick says. The FDA offered a similar pass to drugmakers when introducing universal product codes in 2004, she notes.

The issue isn’t a new one, says former FDA officer and UDI architect Jay Crowley, now vice president and UDI practice lead at USDM Life Sciences. When the FDA considered the question of consignment stocks during development of the UDI final rule, it concluded that two years to UDI implementation plus three years to comply was ample time to use up or relabel supplies.

“For FDA to consider this petition, it will need to consider more broadly the issues of consignment and existing inventory,” he tells IDDM. “It is not clear to me if they really want to do that.”

View the petition at www.fdanews.com/05-25-15-globus.pdf. — Elizabeth Orr

Postmarket Safety

Upcoming Events

  • 21Apr

    CDER’s Most Significant Guidance Priorities for 2021: Biosimilars/Biologics, Generics/Exclusivity, Real-World Evidence, Drug Development and Digital Health

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

  • 06May

    The World of Post-COVID-19 Clinical Trials: How to Prepare for What’s Coming Next

  • 12May

    Extractables and Leachables: 101

  • 19May

    CDRH’s New Accreditation Scheme for Conformity Assessment: Impacts on Your Future Testing Plans and FDA Submissions

  • 25May

    How Can the Accelerated Availability of Pfizer-BioNTech’s COVID-19 Vaccine be Replicated?

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Sanofi-logo.gif

    Sanofi’s Sarclisa Earns Second EC Clearance for Multiple Myeloma

  • emergency use authorization approved

    Qorvo Biotechnologies Earns EUA for Rapid COVID-19 Antigen Test

  • Withdraws cubes

    Zynteglo Gene Therapy Withdrawn in Germany

  • CE mark

    Empowered Diagnostics Earns CE Mark for Rapid COVID-19 Antigen Test

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 My Personal Information
Footer Logo

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

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing