25

Jan

2012

Inc. CuraeLase

0

Recipient: CuraeLase, Inc
Product:CL 1000 IR Laser System
Date: 12/9/2011

Quality System Regulation Concerns

We also note the following concerns regarding Quality System (QS) regulation requirements (21 CFR Part 820):

6. Failure of the DMR for each device type to include or refer to the location of the device specifications, including software specifications, as required by 21 CFR 820.181 (a). For example, there was no documentation of the software specifications and testing of the software user interface and control program. The device has an embedded software program that controls the time elements of the laser and treatments. When the protocol and time treatment duration is selected, the software controls how long the laser is on and the total time, which varies from 5 to 20 minutes.

The embedded software program was developed by the laser (resonator) manufacturer, (b)(4) Although the overall requirements for the software program were communicated between (b)(4), these requirements were not formalized

FDA office: CDRH

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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