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