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Posted On: 03/16/2020 10:40:24 PM
Post# of 11802
Re: DirkEaston #9061
Translation Dirk:
A significant change to FDA policy came out today, and once validation testing has been completed, the test can be distributed with certain labeling and summary of test results provided on the company website. No Emergency Waiver is needed. Any product is granted a waiver without review. The new policy is available at:
https://www.fda.gov/media/135659/download
No FDA review. file your internal testing, put a little squirrly labeling on the package that nobody reads, and you're off to the races.
A significant change to FDA policy came out today, and once validation testing has been completed, the test can be distributed with certain labeling and summary of test results provided on the company website. No Emergency Waiver is needed. Any product is granted a waiver without review. The new policy is available at:
https://www.fda.gov/media/135659/download
No FDA review. file your internal testing, put a little squirrly labeling on the package that nobody reads, and you're off to the races.
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