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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Device registration and listing guidance: New 1guidance explains device facility registration and listing procedures established by the FDA Amendments Act of 2007. Since October 2007, domestic device companies and foreign firms that manufacture or process a device sold in the U.S. have had to register and pay an annual facility registration fee for all their establishments, unless a waiver is granted. The Oct. 8 guidance explains the new, online registration and listing process, and the process for requesting a waiver. Registration is complete once the fee is paid, information is submitted online and the company receives notice from FDA. The registration fee for fiscal 2010 is $2,008, rising to $2,179 in FY 2011 and $2,364 in 2012

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Regulatory News In Brief

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)

Regulatory News In Brief

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)

Recalls In Brief

Synthes recall: Firm is recalling Synex II Central Body components used in its Synex II modular vertebral body replacement system after receiving reports of moderate to severe loss in device height six to 15 months after implantation. The Class I recall could pose "an imminent hazard" to patients, Synthes says, including neural injury, increased pain, spinal kyphosis (a curving of the spine), failure of supplementary fixation, or the need for revision surgery. The firm initiated the global recall Sept. 14, urging surgeons and hospitals to stop implanting the devices and to annually monitor implanted patients through radiographs and pain assessments

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