On March 7, 2002, the Microbiology Devices Panel voted and made recommendations on the classification of previously unclassified preamendment devices to identify Bacillus anthracis and Yersinia pestis. No manufacturer's device submission or application was discussed at this meeting. Devices for B. anthracis and Y. pestis were discussed and voted on separately. For both B. anthracis and Y. pestis the panel determined that these products should be classified as Class II because general controls were not sufficient to provide a reasonable assurance of safety and effectiveness. The Panel believed that there was sufficient available scientific and medical information to establish Special Controls, and that restricted use would offset risks associated with use of these preamendment products (specific bacteriophage, antibody conjugates, and antigens for antibody detection.) They recommended that FDA develop Special Controls, to include testing guidelines and performance characteristics for both devices. There were comments received during both Open Public Hearing sessions.
On the second day, the Panel voted and made recommendations on a PMA Supplement from Digene Corporation for their High Risk HPV DNA nucleic acid hybridization in vitro diagnostic device for the detection of thirteen high-risk types of human papillomavirus (HPV) in cervical specimens. The indications for use were modified to include use as a general population screening test in conjunction with the Papanicolaou smear for women 30 years of age and older, as an aid to determine the absence of high-grade cervical disease or cancer. The Panel voted, 6-2, Approvable with Conditions. The Conditions were 1) Specific recommendations for using the device in clinical management; 2) a demonstration that the device has an impact on clinical outcome. These conditions could be satisfied by evidence based on data derived from longitudinal studies; 3) that educational material be included with the device for laboratory users and clinician; and 4) information from a Post Market surveillance to further assess impact of device and its performance. The Panel recommended that Conditions 1, 2, and 3 be completed before FDA approval. Presentations were made during the Open Public Hearing session from representatives from Association of Obstetrics and Gynecologists (ACOG), the Advocate for Women's Health, and the Association of Reproductive Health Professionals. Statements were submitted by the Society of Women's Health Research, the American Medical Women's Association, and three other interested physicians.
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