• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Steris Corp. settles FDA beef

Steris Corp. settles FDA beef

April 20, 2010 By MedCity News

MedCity News logo

By Mary Vanac

Steris Corp. (NYSE:STE) settled its beef with the Food & Drug Administration, addressing the “violating device” status of its System 1 liquid chemical sterilizer and setting up a transition plan that will enable U.S. customers — mostly hospitals and surgical centers — to trade in their System 1s for rebates.

The terms of the consent decree resolve a two-year dispute with the FDA, which said Steris had changed the System 1 so much since its 1988 launch that the regulator no longer considered it a device approved for sale. A December 2009 safety alert about System 1 from the FDA had cast the pall of financial uncertainty over the Mentor, Ohio-based firm.

The decree also prohibits Steris from selling liquid chemical sterilization or disinfection products that don’t have FDA clearance, formalizes a transition plan for Steris customers and describes other process and compliance issues, according to a press release. The decree is subject to approval by the U.S. District Court for Northern Ohio.

“We are pleased that our plans for financial assistance and other support we will provide System 1 customers during this transition are now final,” said Walt Rosebrough, the company’s president and CEO, in the release.

“We apologize to our customers for the uncertainty this situation created over the last several months. However, we believe the transition plan will allow healthcare providers the time, financial support and information necessary to make the best possible decisions for patients and caregivers,” Rosebrough said. “We also appreciate the FDA’s efforts to accommodate the needs of health care providers and the patients they serve during this transition.”

Two weeks ago, the FDA cleared the company’s next-generation liquid chemical sterilizing system — the Steris System 1E — after reviewing the company’s marketing application for more than a year. Steris hopes to deliver the first System 1Es by the end of the third quarter.

Filed Under: Business/Financial News, News Well, Sterilization / Calibration Tagged With: Steris Corp.

More recent news

  • Comphya raises CHF 7.5 million for neurostim to treat ED
  • Fujifilm launches intelligent automation features for digital radiography
  • Integer appoints former iRhythm CEO to board
  • MMI debuts robotic surgery instruments, digital surgery platform
  • Synchrony Medical wins FDA nod for airway clearance system

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy