Roche Diagnostic Corp.

Company:Roche Diagnostic Corp..
Product:Tecan Clinical Workstations, Online TDM Phenytoin diagnostic test kit
Date: 9/2/04

Failure to implement procedures to ensure that all purchased products and services conform to specified requirements, as required by 21 CFR 820.50(a) and (b). Specifically, you failed to follow your procedure for adding suppliers of hardware and software accessories used in the devices to include:

-A record that adequate quality requirements are met.
-A record that the supplier has been sufficiently evaluated.
-A record showing the type and extent of control to be exercised over this contractor has been clearly defined.
-Established purchasing information including specified requirements for the products and services to be received.
See the 5/26/04 FDA-483 # 3.

Failure to include in the Device Master Record (DMR) for the devices a reference to the location of the device and software specifications, as required by 21 CFR 820.181. See the 6/26/04 FDA-483 # 5.

FDA District: Detroit District Office

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.