FDA Moves to Dismiss Lawsuit Challenging Device Reclassification Petition Denial

On March 24, 2008, FDA asked the U.S. District Court for the District of Connecticut to dismiss a January 22, 2008 Amended Complaint alleging that the Agency improperly denied HiFi DNA Tech, LLC’s petition for reclassification of an HPV nested DNA polymerase chain reaction (PCR) detection device to Class II.  As stated in HiFi’s Amended Complaint, the company’s device is intended to be used for preparation of sample materials for accurate HPV genotyping by direct automated DNA sequencing.  HiFi asked the Court to review and reverse the denial of its reclassification petition, or to declare the denial invalid and to order FDA to conduct an unbiased review of the reclassification petition. 

HiFi submitted a 510(k) premarket notification to FDA on December 7, 2006, requesting that the Agency deem the new device substantially equivalent to Digene’s Hybrid Capture 2(hc2) High-Risk HPV DNA test.  Digene’s test was approved by FDA as a Class III device under the premarket approval process.  Consequently, on January 9, 2007, FDA rejected HiFi’s premarket notification and determined the device to be a Class III device.  FDA states in its Motion to Dismiss that HiFi could not demonstrate that its device was substantially equivalent to a predicate device that did not require premarket approval.  HiFi then submitted a request for de novo review.  FDA deemed the device ineligible for de novo review because it was of the same type as Class III devices; two other HPV detection devices have been approved as Class III devices. 

On March 7, 2007, HiFi submitted to FDA a petition to reclassify its device as Class II.  FDA denied the petition on December 14, 2007.  In its Amended Complaint, HiFi alleges that FDA’s review of the petition did not “follow established FDA procedures” in that the Agency did not forward the petition to the FDA Commissioner or to a classification panel for review.  However, FDA has discretion as to whether to refer a reclassification petition to a panel; as FDA points out in its Motion to Dismiss, 21 U.S.C. § 360c(f)(3) says the “Secretary may for good cause shown refer the petition to an appropriate panel.”  The legislative history of this section confirms that Congress wanted FDA to have such discretion.  HiFi alleges that FDA improperly compared its device to Digene’s test, as that test (which HiFi used as the predicate device in its premarket notification) uses a different scientific basis to determine the presence and type of HPV in a sample.  HiFi further alleges that FDA’s denial of its reclassification petition results in “FDA’s over-regulation of the device as a cancer test rather than as a test for a common virus . . . in violation of the least burdensome [standard] . . . and at the expense of public interest.”  According to HiFi, the denial was inappropriate and applied an incorrect scientific standard to the device.  The company challenges FDA’s assertion that the device is intended for use in evaluating cancer risk.  FDA maintains that many cancers of the cervix are associated with HPV infection and that if used as intended, HiFi’s device will guide patient management decisions to refer a woman for further cervical cancer screening.  Further, FDA reveals in its Motion to Dismiss that HiFi’s own submissions to the Agency referenced professional Guidelines for cervical cancer screening. 

FDA states that it evaluated all of the scientific evidence to determine that HiFi’s device does not meet the statutory criteria for Class II.  FDA’s Motion to Dismiss cites inadequacies in HiFi’s data including that performance characteristics, clinical sensitivity and specificity, cross-reactivity, and the rate of false negatives could not be assessed.  Moreover, HiFi described its device as being used in conjunction with HPV genotyping to confirm positive HPV DMA results, but FDA’s Motion to Dismiss asserts that the company did not submit any evidence to establish that HPV genotyping has been clinically validated for diagnostic use in relation to cervical cancer.  According to FDA, HiFi failed to provide the Agency with sufficient evidence to establish special controls to assure the safety and effectiveness of the device for its intended use.  FDA’s Motion to Dismiss argues that the administrative record of its review of HiFi’s submissions supports its decisions, and that the Agency acted within its authority.  HiFi faces an uphill battle in this litigation.

By Christine P. Bump