August 18, 1999
CRS-USA LASIK 8/18/99 Clinical Trial Software Validation There was no verification that the data submitted by the clinical investigators matched source data at the site. The only data verification was performed by the computer data service, xxxx and involved scrutinizing the data for such errors as out-of-range data, field entry omissions, exam dates out-of-range, and...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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