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 & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Hands Cardiac Designs Warning Letter for Validation Failures

FDA Hands Cardiac Designs Warning Letter for Validation Failures

November 13, 2015

Round Rock, Texas-based Cardiac Designs received an Aug. 7 warning letter for design validation failures, inadequate complaint handling procedures and CAPA failures for its mobile heart monitoring device.

The FDA cites Cardiac Designs for not conducting validation studies to ensure the device meets user needs under actual conditions. Specifically, the company did not have any records demonstrating ECG Check Application software was validated, despite design validation SOPs that required software validation be maintained in the design history file.

The company also failed to document and evaluate complaints. A complaint log showed 87 complaints between April 4, 2014 and June 15, 2015, but they were not documented on a customer complaint report form. In addition, there were no records showing the complaints were even reviewed to determine if an investigation was warranted, the warning letter says.

Cardiac Designs also did not follow its SOPs for corrective and preventive actions. For example, a CAPA was opened on Dec. 30, 2013, to address a finding that the device’s risk management report “incorrectly identified labeling as mitigation of risk.” The CAPA states that the risk management report would be updated, but there was no record that it was corrected.

Another CAPA was opened in October 2014 after a third-party audit identified CAPAs were not being fully documented, and the company committed to providing additional training. However, the FDA inspector found “no record of these verification activities.”

The warning letter says that Cardiac Designs failed to develop, maintain and implement medical device reporting procedures, and that the company did not have definitions for what was considered a “reportable event.”

Cardiac Designs did not respond to a request for comment.

The first crucial question devicemakers must answer is when a process must be validated. Order our report Process Validation: A Guide for Devicemakers, which will walk you through each point in the decision-making process, including how to determine if a product can be “fully verified,” and how FDA inspectors define that term.

Medical Devices Inspections and Audits

Upcoming Events

  • 01Feb

    The Future of QMS: Will the Recent Announcement and Delays Have a Global Impact?

  • 08Feb

    Process and Design Validation for Devicemakers: A Deep Dive into Best Practices, Recent Trends and Regulatory Definitions

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 22Feb

    Best Practices for Developing and Maintaining a GxP Training Matrix

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • Wandercraft Walking Robotic Exoskeleton Gets FDA Clearance for Stroke Rehab

  • Better Business Bureau Flags Novartis Advertising for Kisqali

  • NeuroMetrix Launches DPNCheck 2.0 for Peripheral Neuropathy Screening

  • Syros Gets Fast Track Status for Higher-Risk Myelodysplastic Syndrome Candidate

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