Apr

2005

Pace Tech Inc.

Recipient: Pace Tech Inc.
Product: Stationary and portable patient monitors
Date: 4/29/05

Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures as required by 21 CFR 820 .75(a). Your firm fails to conduct adequate process validation in that soldering (baking) validation is not documented and there is no validation of software used in the complaint repair system to document previous repairs to devices.

Your response dated March 18, 2005 addressing FDA 483, Item #12A & B is inadequate because there is no evidence of a validation protocol or actions that have been taken to date for both your soldering process and changes made to software.

FDA District: Florida District Office

About the author

Amy Sellers

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.

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Pace Tech Inc.

Amy Sellers

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