Biomet provides explanation to FDA regarding marketing rights for Signature Personalized Patient Care system

Aug 18 2010

Biomet received a Warning Letter from the U.S. Food and Drug Administration (FDA) regarding the Signature™ Personalized Patient Care system, alleging that Biomet does not have appropriate clearance or approval to market the system in the United States.

Biomet responded to the Warning Letter on August 3, 2010, explaining why the company believes that the Signature™ Personalized Patient Care system, which is manufactured by Materialise NV, has been appropriately marketed under a 510(k) premarket clearance. The company has not received a formal response to its August 3rd letter to the FDA.

Biomet is committed to working with the FDA to resolve the issue in the best interests of patients and their doctors without disruption to patient treatment.

Source:

: Biomet

Posted in: Healthcare News

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