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 FDA’s 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

                HiFi’s President, denying HIFi’s 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 HiFi’s 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 Device’s 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 HiFi’s reclassification

                petition on December 14, 2007. AR 493.

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                Link to: Motion to Dismiss Amended Complaint

                Link to: Memo of Opposition

                Link to: HiFi DNA Tech, LLC