DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 4Y837cl

Transcription

1 DEPARTMENT OF HEALTH & HUMAN SERVICES Pubic Heath Service 4Y837c WARNING LETTER Food and Drug Administration Center for Devices and Radioogica Heath 2098 Gaither Road Rockvie, MD VIA FEDERALEXPRESS _ Thomas J. Peters, M.D. 651 West Mingus Avenue, Suite 1F Cottonwood, Arizona Dear Dr. Peters: This Warning Letter informs you of objectionabe conditions found during a Food and Drug Administration (FDA) inspection conducted at your cinica site. Ms. Diane C. Van Leeuwen, an investigator from FDA s Los Angees District Office, conducted the inspection on Apri 12,2004. The purpo activities as a cinica investigator for-the is a device as defined in section 201(h) of the Federa Food, Drug, and Cosmetic Act (the Act) The FDA conducted the inspection under a program designed to ensure that data and information contained in requests for Investigationa Device Exemptions (IDE), Premarket Approva Appications (PMA), and Premarket Notification [ 51 O(k)] submissions are scientificay vaid and accurate. The program aso ensures that human subjects are protected from undue hazard or risk during scientific investigations. Our review of the inspection report prepared by the district office reveaed serious vioations of Tite 2 1, Code of Federa Reeuations (2 1 CFR), Part 8 12-Investigationa Device Exemptions, 21 CFR Part 50-Protection of Human Subjects, and Section 520(g) of the Act. At the cose of the inspection, Ms. Van Leeuwen presented a Form FDA 483 Inspectiona Observations to you for review and discussed the isted deviations. The deviations noted on the FDA 483 and our subsequent inspection report review are discussed beow: 1. Faiure to adhere to the genera and specific responsibiities of an investigator (21 CFR ,21 CFR ,21 CFR and (a)(5)). In accordance with 2 1 CFR and I IO, investigators are responsibe for maintaining contro of devices under investigation and for ensuring that an investigation is conducted according to the signed +,:I-cement, the investigationa pan, and appicabe FDA reguations. As required by 21 CFR and 21 CFR 50.20, an investigator must ensure informed consent is obtained from the subject or the subject s egay authorized representative prior to his or her participation in an investigationa study. If

2 Page 2 - Thomas J. Peters, M.D. informed consent is not obtained because of emergency use, investigators are responsibe for reporting such use of the investigationa device to the sponsor and reviewing IRB within five working days after the use occurs (21 CFR (a)(5)). You faied to satisfy these requirements. Exampes of this faiure incude but are not imited to the foowing: On May 6, 2002, you impanted the investigationa device into Subject-who was not enroed in the study and who did not sign the required informed consent form. Furthermore, you did not have IRB approva, did not ensure informed consent was obtained prior to impanting the investigationa device into Subject m, and did not report use of the investigationa device to the reviewing IRB. The IRB initiay approved the study on February 27,2003, which was nine months after the impantation into Subject- During the inspection, you stated that the use of the investigationa device with respect to Subject -was as a custom device and for prescription and compassionate uses; you said that you were not sure why you thought that the device was acceptabe to be used; and you acknowedged that you did not have the appropriate approva for compassionate use. The custom device exemption appies to devices that meet a narrow and specific set of statutory requirements set forth in section 520(b) of the Act. The devices you impanted did not meet these requirements, nor those described in 21 CFR 812.3(b) for custom devices. Custom devices are imited to those intended for use by an individua patient named in a physician s order and made in a specia form for that patient. (2 1 CFR 812.3(b)(S)). Th ese devices aso fai to meet the exemption set forth in 21 CFR 812.2(c)(7). Furthermore, FDA reguations do not provide for the prescription use of an unapproved device currenty under an IDE. It is important for cinica investigators to understand that uness the physica safety of a subject demands otherwise, treatment of study subjects must adhere to the requirements of an investigationa pan. (21 CFR ). In accordance with 21 CFR (a)(2), deviations from the investigationa pan are permitted when necessary to protect the ife or physica we-being of a subject in an emergency. FDA s Guidance on IDE Poicies and Procedures, which incudes a section on emergency use of unapproved devices, can be found on the Internet at The guidance document speaks to those situations in which an investigationa or unapproved device, respectivey, is needed to save the ife of a patient or to prevent irreversibe morbidity. At the same time, however, FDA recognizes that there are circumstances in which an investigationa device is the ony option avaiabe for a patient faced with a serious, abeit not ife-threatening condition (hereinafter referred to as compassionate use ). In these circumstances, FDA uses its reguatory discretion in determining whether such use of an investigationa device

3 Page 3 - Thomas J. Peters, M.D. shoud occur. For more information about compassionate use, you may aso refer to the above-referenced guidance docutent. Unike emergency use of an unapproved device, prior FDA approva is needed before compassionate use may occur. In order to obtain Agency approva, the sponsor shoud submit an IDE suppement requesting approva for a protoco deviation under 21 CFR (a). 2. Faiure to maintain accurate, compete, and current records (21 CFR (a)). FDA reguations require investigators to maintain accurate, compete, aid current records of receipt, use, or disposition of a device (21 CFR (a)(2)). You faied to satisfy this requirement. Exampes of this faiure incude but are not imited to the foowing: Copies of receipt and disposition of the investigationa devices were missing from the study records. For exampe, the Kit Router document shows tham ere returned ande investigationa device with ot s missing. However, the impant shows that this patient received ot Furthermore, the Kit Router shows that the investigationa device with ot -a4119ydi was returned; however, the impant usage ticket for Subjec & shows that this patient received this device. Due to this discrepancy, FDA coud not determine which investigationa device was impanted into the patient. In addition, during the cose-out discussion, Ms. Van Leeuwen mentioned to you that theomonth postoperat fims and reports were missing from the records of Subject Pease provide copies of the x-ray report for this patient with your response. The above-described deviations are not intended to be an a-incusive ist of deficiencies that may exist at your cinica site. As a cinica investigator, it is your responsibiity to ensui-e that investigations in which you participate are conducted in accordance with a appicabe requirements of the Act and FDA s reguations. Within 15 working days after receiving this etter pease provide written documentation of the specific steps you have taken or wi take to correct these vioations and prevent the recurrence of simiar vioations in current and future studies. Any submitted corrective action pan must incude projected competion dates for each action to be accompished. Faiure to respond to this etter and take appropriate corrective action coud resut in the

4 Page 4 - Thomas J. Peters, M.D. FDA taking reguatory action without further notice to you. In addition, FDA coud initiate disquaification proceedings against you in accordance with 21 CFR Send your response to: Food and Drug Administration, Center for Devices and Radioogica Heath, Office of Compiance, Division of Bioresearch Monitoring, Program Enforcement Branch II, HFZ-3 12,2094 Gaither Road, Rockvie, Maryand 20850, Attention: Linda Godfrey. We are aso sending a copy of this etter to FDA s Los Angees District Office, and request that you aso send a copy of your response to that office. If you have any questions, pease contact Linda Godfrey by phone at extension 134 or by emai at bnda.nodfrev@fda.hhs.gov. Office of Compiance Center for Devices and Radioogica Heath

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