The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) has reviewed various portions of the labeling for the Valeo™-C VBR, which was provided by Amedica Corporation to inspectors from the Denver District Office during an inspection which took place between August 7 and August 20, 2008, and learned that your firm is marketing the Valeo™-C VBR for new intended uses without marketing clearance or approval. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), the Valeo™-C VBR is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
The device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), in that a notice or other information respecting the device for the new uses described below was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 C.F.R. 807.81 (a)(3)(ii). Your promotion of the Valeo™-C VBR for intended uses that are not consistent with those cleared in your 510(k) Notifications represents a major change or modification in the intended use that requires the submission of a PMA or a 510(k). For a device requiring premarket approval before marketing, the notification required by section 510(k) of the Act is deemed satisfied when a premarket approval application (PMA) is pending before the agency, 21 C.F.R. § 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.