Case 3:08-cv-00054-AVC     Document 13      Filed 03/24/2008     Page 18 of 43



                for unreasonable delay under the APA. HiFi DNA Tech, LLC v. HHS, No. 07-1511 (D. Conn.


                Oct. 12, 2007). Following FDAís ruling on the reclassification petition in December 2007, HiFi


                voluntarily dismissed that suit.


                V.    THE FDA ORDER


                        On December 14, 2007, FDA issued a detailed, 14-page Order, in the form of a letter to


                HiFiís President, denying HIFiís petition for reclassification of the HPV Device from Class III to


                Class II. AR 491-501. As shown below, FDA evaluated all of the scientific evidence and


                determined that HiFiís device had not met the statutory criteria for a Class II device. Further,


                FDA considered the arguments raised by plaintiff and determined that they were without merit.


                Specifically, FDA determined that there were numerous inadequacies in the data submitted by


                HiFi, such that the HPV Deviceís basic performance characteristics, including its clinical


                sensitivity and specificity, cross-reactivity, and rate of false negative test results, could not be


                assessed. AR 297-307, 499-504. Even more fundamentally, FDA found that HiFi intends for its


                device to be used in conjunction with genotyping to confirm its positive test results, but HiFi did


                not submit any data demonstrating that an HPV genotyping test validated for diagnostic use with


                cervical cancer even exists. AR 296-308, 500-02. For these reasons, HiFi failed to meet its burden


                of proving that its HPV Device meets the requirements for reclassification.






                May 22, 2007. CDRH relied upon this official filing date and believed that a response was not due

                until December 18, 2007, which would have been 210 days from the official filing date. The error was

                discovered only after HiFi filed its original lawsuit in October 2007. FDA ruled on HiFiís reclassification

                petition on December 14, 2007. AR 493.




                Link to: Motion to Dismiss Amended Complaint

                Link to: Memo of Opposition

                Link to: HiFi DNA Tech, LLC