FDA Issues Final Rule On Electronic Registration And Listing Of Devices
This article was originally published in The Gray Sheet
The rule formally implements requirements established by the FDA Amendments Act of 2007.
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Stryker resolves another warning letter: The firm has resolved the second of four warning letters received since 2007 related to quality issues, Stryker reported March 23. Following a 2009 re-inspection and further corrective actions, FDA determined the company had sufficiently addressed a November 2007 warning letter for quality system problems at its reconstructive implant manufacturing facility in Mahwah, N.J. No further formal corrective actions are required, Stryker said. Last fall, FDA lifted another of the warning letters, this one for quality system and compliance violations at the orthopedic device maker's biotech division (1"The Gray Sheet" Oct. 26, 2009). Stryker initiated a three-year, roughly $200 million compliance program overhaul in 2008 (2'The Gray Sheet" Feb. 2, 2009)