Regulatory Briefs: IVD Draft Guidance; Dispute Panel; Risk Communication
This article was originally published in The Gray Sheet
FDA releases draft guidance on human leukocyte antigen test kits. Wright Medical announces its Augment bone graft will go to FDA’s Dispute Resolution Panel. More news.
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The agency has agreed to accept Wright Medical’s PMA amendment for its embattled Augment bone graft, saving the firm from going to a dispute resolution panel this spring.
FDA granted FzioMed’s petition for an independent review of its Oxiplex gel PMA by the Medical Devices Dispute Resolution Panel in response to FzioMed’s November 2012 petition. The agency deemed the device, intended for use in spine surgery, as “not approvable” in 2008.
According to plaintiffs in California federal court, P&G’s claims on Herbal Essences and Pantene shampoo and conditioner products about high proportions of natural-origin or naturally derived ingredients are false and/or misleading, and ISO 16128 certification does not cure the deception.