CDRH BiMo untitled letters.

The following untitled letters were issued by the Division of Bioresearch Monitoring of the Center for Devices, Office of Compliance (CDRH-OC) in 2002. Copies of these letters are available to subscribers from RECORD-RETRIEVE for $7 plus retrieval.

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Thomas Abell, M.D., Lexington, KY, Apr. 6, 2002 (CDRH-OC). Cincinnati District investigator Gina Brackett conducted the Jan. 14-22, 2002, inspection to determine the clinical investigator's compliance in an unnamed excimer laser study. The inspection revealed Abell lacked IRB review and approval of a protocol change prior to implementation. Additionally, the clinical investigator lacked similar approval concerning information he had posted on a website concerning the study, the letter stated. BiMo, Web

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Acculaser, Inc., San Diego, CA, March 18, 2002 (CDRH-OC). Los Angeles District investigator Allen Hall inspected the sponsor of an unnamed device trial from Nov. 20, 2001 to Jan. 23, 2002. The agency found that Acculaser failed to obtain an adequate investigator's agreement to "state a commitment to ensure informed consent requirements were met," and to ensure that laser technicians followed FDA regulations during the study. BiMo

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Mark Anton, M.D., Newport Beach, CA, June 11, 2002 (CDRH-OC). The inspection was conducted to determine the clinical investigator's compliance in an unnamed IDE study. FDA hit Anton with failure to report adverse device events to the unnamed sponsor or IRB regarding a reportable event that occurred on Feb. 11, 2000, was not reported until Oct. 19, 2001. The letter also hit the investigator with failing to maintain adequate records of receipt, use or disposition of the device in 57 implant cases. Los Angeles District investigator Allen Hall conducted the inspection April 15-18, 2002. BiMo

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Florida Heart Associates, Fort Myers, FL, May 16, 2002 (CDRH-OC). The letter stated that the clinical site failed to conduct a required investigation when it "allowed other physicians to participate" in the unnamed study. The agency also hit Florida Heart for deviating from a Sept. 21, 1998, Investigator's Assurance agreement in that research data was not provided to the coordinating center in a timely manner. FDA also stated the site's informed consent documentation did not provide a statement "that the study involves research." Florida District investigator Keith Schwartz conducted the March 4-8 and 14, 2002, inspection. BiMo

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Florida Hospital, Orlando, FL, March 4, 2002 (CDRH-OC). Florida District investigator Ronal Weber reviewed the IRB from Sept. 24-28, 2001, and found it failed to have adequate written procedures for conducting initial or continuing review of research, the letter stated. FDA also stated that the IRB failed to conduct research reviews as described in its written procedures in that "existing procedures" required investigators to report all protocol violations within five days; the IRB notified investigators "to restrict their reporting to only 'significant' violations for all studies." The agency also hit the hospital for not maintaining adequate documentation of correspondence with its clinical investigators. BiMo

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Lifecore Biomedical, Inc., Chaska, MN, April 18, 2002 (CDRH-OC). The letter cited the sponsor of the unnamed clinical trial with failure to maintain accurate, complete and current records relating to adverse device events occurring between October 1999 and February 2000. Lifecore also failed to prepare and submit complete, accurate and timely progress and final reports and failed to include in its PMA "an identification, discussion, and analysis of any other data, information, or report relevant to an evaluation of the safety and effectiveness" of the device. Specifically, the agency took issue with adverse events, which occurred 19 to 23 months prior to a Dispute Resolution panel meeting that were not identified in the PMA. Minneapolis District investigator Sharon Matson inspected Lifecore Dec. 17-20, 2001. BiMo

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Naval Health Research Center, San Diego, CA, July 25, 2002 (CDRH-OC). Los Angeles District investigator Thomas Beilke inspected the IRB Jan. 30-Feb. 5, 2002, and found it failed to prepare and maintain adequate documentation of IRB activities related to continuing review and reports submitted by investigators in the unnamed study. The agency also hit the IRB for not following written procedures for determining which projects needed verification from sources other than the investigator to ensure that no material changes had occurred since the previous review, and to ensure prompt reporting to FDA of any unanticipated problems involving risks to human subjects. BiMo

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Sub-Q, Inc., San Clemente, CA, March 19, 2002 (CDRH-OC). An unnamed Los Angeles District investigator inspected the firm Dec. 5-11, 2001, and found it failed to ensure that 19 out of 29 investigators participating in the unnamed IDE study had signed an investigator agreement. The FDAer found that physicians who did not sign the agreement made eight out of 20 known protocol deviations in the study. The agency also hit Sub-Q for not taking actions to ensure that investigators were complying with protocols, and for inadequate monitoring of the study. BiMo