Thoratec Gets 483 for Lax MDR Reporting
Thoratec, a California-based maker of heart disease-treating equipment, failed to thoroughly investigate and submit a timely MDR for a complaint involving a patient’s death, according to a Form 483.
Thoratec did not submit an MDR within 30 days of receipt, as required for cases of reported death, the FDA said. The devicemaker submitted the MDR on Aug. 18, 2010 — four months after receiving the complaint.
The agency followed up the form with a warning letter noting an inadequate response by the devicemaker to a complaint for its Ventricular Assist device.
And these aren’t the only types of MDR violations the FDA is looking for. It’s no longer good enough to say your complaint management system is compliant with CFR Part 820. The agency would also like it integrated with multiple other sections of the CFR and international regulations.
Companies that still rely on a paper system will have to install new software that must be validated. Estimates of the cost of full industry compliance are in the $58 million to $80 million range.
Get on the right side of this change — before it hits. Sign up for Medical Device Complaint Management: Taming “Out of Control” Systems to Assure Compliance.
You’ll discover tips to continuously evaluate your systems for compliance, which records you must keep to show you are obeying the rules and how to take a holistic view to assure you’re complying with the many requirements.
Don’t miss this amazing webinar Thursday, March 22. You’ll get all the information you need without having to leave your office. Register today.