2001D-0044 Clinical Laboratory Improvement Amendments of 1988
FDA Comment Number : EC4
Submitter : Dr. Valerie Ng Date & Time: 12/05/2005 01:12:23
Organization : Alameda County Medical Center/Highland Genl Hosp
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
This is a great document. It clearly and concisely states the minimum requirements for bringing a device to the FDA for waiver consideration.

As a member of CLIAC who has advocated for these guidelines, as an "end user" of these products, and as one who has to often troubleshoot when these products are perceived as not working properly, I will be very comforted with the knowledge that any future FDA-approved waived test device approved under these guidelines has undergone a standardized and reasonably rigorous and statistically sound premarket evaluation.

I especially like the recommended statistical analysis - encompassing the entire process from how many specimens to test, how many sites, over what period of time, to how to analyze the data. Very nice. Do not change any of this.

I also very much like the requirement to have the intended user be the group to evaluate the device in its intended setting. This requirement will mimic the real life and intended use of the device, and will hopefully identify early on any device issues that can be addressed prior to FDA submission and market release. Do not change this requirement.

Finally, one small recommendation. The CDC just published "Good Laboratory Practices for Waived Testing Sites" in the November 11, 2005 MMWR. The section in this document relating to labeling for waived devices (Section V) should include a reference to this recent publication. If this reference is included in the manufacturer's instructions, end-users would then be automatically aware of an easily available resource that defines good laboratory practice when waived devices are used.