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STATE HEALTH OFFICIALS TO CONDUCT ABOUT 180 DEVICE FIRM INSPECTIONS IN FY 1994

This article was originally published in The Gray Sheet

Executive Summary

STATE HEALTH OFFICIALS TO CONDUCT ABOUT 180 DEVICE FIRM INSPECTIONS IN FY 1994 (year ending Sept. 30) under contracts signed with FDA. On Sept. 30, the Departments of Health of Colorado and Texas entered contracts with FDA that give the states authority to inspect manufacturers of Class II and Class III medical devices to determine compliance with good manufacturing practice regulations. Colorado was contracted to conduct 30 inspections during the fiscal year, while Texas was contracted for 50. An expected contract with California should bring the number of state-conducted inspections up to about 180 for the year. The agency is hoping that the assistance of the states will help it come closer to meeting the statutory requirement of inspecting device firms every two years. In the contracts, FDA notes: "In light of the current -- and future -- federal fiscal realities, it is unlikely that the agency will obtain more inspectional resources to dedicate to its inspectional needs." The two contracts represent a first step in an attempt "to use state contract funds to procure some inspectional capacity from qualified states to address its GMP inspectional needs," the agency adds. If the inspection program is successful in the initial states, FDA plans to sign contracts with additional states. FDA will train state inspectors during the fall; the agency anticipates that state-run manufacturer inspections will begin by early 1994. Inspector training will consist of both classroom and field instruction. Inspectors will be required to attend formal training either at FDA headquarters in Rockville, Maryland, or at a site yet to be determined. The training will consist of "detailed information on the requirements of the GMP, MDR [medical device reporting] and other FDA regulations" as well as "information re: liaison activities with the appropriate District offices." State inspectors will also be required to participate in two comprehensive joint inspections alongside FDA inspectors. The training program is expected to take up to three months. FDA expects that between three and five inspectors each will be trained in Colorado and Texas. The inspectors designated by the states for FDA training, the contracts note, should have "appropriate educational background and experience," including "a minimum of 30 credit hours of college-level courses in the natural sciences or engineering" and experience in conducting state inspections. The inspectors will have the status of "state officials who have been commissioned as officers of the Department of Health and Human Services...under the authority of the Food Drug and Cosmetic Act," the contracts note. Commissioned officers must conform with the "procedural requirements of the Act including the use of credentials, and issuance of Notice of Inspection, Inspectional Observations, and Receipt for Sample forms." The contract awarded to Colorado was for roughly $94,500, while the contract for Texas was approximately $122,000. However, the amount going towards the actual manufacturer inspection procedure is roughly $53,200 for Colorado and $33,500 for Texas. The balance of both awards will be used for reimbursement of travel and training expenses.
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