DEPARTMENT OF HEALTH &. HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard 3 I 2C06 Mediscience Technology Corporation c/o Robert Schiff, Ph.D. RAC President Schiff & Company Re: I040553/S003 and S004 Dated: January 4 and 17, 2006 Received: January 5 and 19, 2006 Q060019 Feasibility Study of Optical Biopsy Device for Cervical Cancer Detection Request for Determination about Significant Risk Investigation Dear Dr. Schiff: The Food and Drug Administration (FDA) has reviewed your submission, dated entitled "A Multicenter Pilot study to establish the Safety and Parameters of Efficacy of an Optical Biopsy Device (CDR) for Cancer Detection of Cervix Preliminary to a Pivotal Study. "FDA has determined that your proposed clinical investigation is a non-significant risk (NSR) device study because it does not meet the definition of a significant risk (SR) device under ss. 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812, enclosed). However, this decision is based on a specific worst case scenario for UV exposure at a single measurement at 380 and 340 run and two exposures each at 300 and 289 run. If you anticipate exceeding this worst case scenario by delivering multiple exposures at 380 nm or any other wavelength, a new worst case scenario should be identified and submitted with a revised safety analysis. An IDE application is not required to be submitted to, or approved by, FDA for a NSR study. A NSR study is, however, subject to the abbreviated requirements described in ss. 812.2(b) of the IDE regulation. The abbreviated requirements stipulate that the sponsor of the investigation must label the device in accordance with ss. 812.5; obtain institutional review board approval of the investigation as a NSR study; ensure that each investigator obtains informed consent from each subject under the investigator's care; comply with the monitoring requirements of ss. 812.46; maintain records required under ss. 812.140(b)(4) and (5) and file the reports required under ss. 812.150(b)(1) through (3) and (5) through (10); and ensure that participating investigators maintain the records required by ss. 812.140(a)(3)(i) and file the reports required under ss. 812.150(a)(1), (2), (5) and (7). Under the abbreviated IDE requirements, a sponsor must also comply with the prohibitions against promotion and other practices as identified in ss. B 12.7. According to this section of the regulation, the sponsor of a NSR study, investigator, or any person acting for or on behalf of the sponsor or investigator is prohibited from promoting or test marketing the investigational device until after FDA has approved the device for commerciai distribution; commercializing the device by charging a price greater than that necessary to recover the cost of manufacture, research, development, and handling; unduly prolonging the investigation; and representing the investigational device as being safe or effective for the purposes for which it is being investigated. If you have any questions regarding our NSR detennination or the abbreviated IDE requirements, please contact Mridulika Virmani, Ph.D. at (301) 594-1180. Sincerely yours, /s/ Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device and Radiological Health |