Device Manufacturer NuVasive Chided by FDA For Marketing Device Using Unapproved Claim
Posted 19 March 2013 | By
The US Food and Drug Administration (FDA) has accused medical device manufacturer NuVasive of marketing its Affix Spinous Process Plate Systemic device without an approved application, rendering it misbranded and illegally marketed.
The allegations are contained within a 12 March 2013 warning letter sent to the company and made public on 19 March 2013. In it, regulators reference a 29 October 2012 investigation of the firm's San Diego, CA manufacturing facility.
"Our inspection revealed that the Affix Spinous Process Plate System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g)," FDA wrote.
The orthopedic device has several cleared 510(k) applications, of which the relevant one (K073278) was found to be substantially equivalent to an earlier predicate device in March 2008.
At issue, FDA said, was that the device claims to be indicated for the "ILIF Surgical Technique" in which the Affix plate is used "as an adjunct to interbody fusion."
"Although your firm has multiple 510(k)s cleared for this device, none of them include the use of the Affix plate with only an intervertebral body fusion device," FDA explained. "This constitutes a new intended use and a new 510(k) is required in accordance with 21 CFR 807.81(a)(3)(ii)."
FDA's letter goes on to ask that the manufacturer stop marketing the device using the claim immediately and to respond to the letter within 15 days.