Posted by Sten Westgard, MS
Dr. Westgard talks about the new era of QC at the Thermo Fisher workshop.
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
As many of you know, the FDA has issued new draft guidelines about Blood Glucose Monitoring Test Systems for Industry and Manufacturers.
Recently, the AACC held an excellent webinar where an Dr. Courtney Lias, PhD from the FDA discussed the intentions of the new guidances and then fielded a LOT of questions. I don't want to step on what Dr. Lias and the AACC accomplished during their webinar. There was useful information in that presentation and I encourage others to consider getting those materials once they become available on the AACC website.
However, while reading through the guidances and talking to laboratories these past few months, I thought I might share a few observations...
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Posted by Sten Westgard, MS
As many of you know, EQC is out and IQCP is in. As the expiration date for EQC approaches in 2016, labs need to learn more ab
out Risk QC and IQCPs. CMS has an email address where you can send questions.
We tried out the question and answer line with CMS, see the results after the jump...
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
A recent New York Times Sunday editorial focused on the deplorable state of medical device regulation. We simply can no longer trust FDA clearances, particularly 510ks:
Posted by Sten Westgard, MS
The fallout of the IDVR continues. An interesting quote from a recent paper: "Although the EC aimed at bringing safe and effective medical tests to the EU-market, ~9,000 tests out of ~40,000 tests got lost in transition." Nearly a quarter of tests suddenly became unacceptable? That places IVDR at just above 2.2 Sigma. The proposed soluti...
A recent question came to me via social media: "Hello Sir, Good morning, How are you? I wanted to know is still 10x rule is coumpulsary?[stet.] Even [when] we are using lab mean and lab SD. Please share the details.Thanks and Regards, [anonymous]"10:x is not compulsory by any regulation that I am aware of. Many regulations require you to...