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DEVICE CENTER REVIEW OF STANDARDS DEVELOPMENT ACTIVITIES

This article was originally published in The Gray Sheet

Executive Summary

DEVICE CENTER REVIEW OF STANDARDS DEVELOPMENT ACTIVITIES is slated to begin in early July, according to staffers at FDA's Center for Devices and Radiological Health. The program review is being undertaken to "be sure our level of participation is consistent" with device center priorities, CDRH Director Bruce Burlington said in a recent memo. The review will be headed by CDRH's office of standards and regulations and will involve staffers from the other major CDRH offices such as device evaluation and compliance. Recommendations on which standards activities to continue and which to eliminate will be made to device center managers later in the year, according to FDAers. Factors that the review committee will take into consideration in evaluating CDRH standards activities include the existence of other, similar standards for a device type and the potential risks posed by a device. The center also is likely to place higher priority on international standards activities, FDAers say. In addition to its own standards-writing activities, CDRH participates in a number of standards groups, such as the International Standards Organization, the International Electrotechnical Commission, the American National Standards Institute and the National Committee of Clinical Laboratory Science. The standards program review is one of at least two CDRH initiatives aimed at more closely linking device center activities with regulatory responsibilities. A similar review of the device center's research program is slated to begin on June 30, when a program review steering committee will hold its first meeting. The steering committee, formed the week of June 21, is being co- chaired by Lillian Gill, interim director of CDRH's office of science and technology, and Thomas Callahan, an associate director of the division of general and restorative devices at the office of device evaluation. The committee also includes Jerry Collins, director of the office of research resources at the Center for Drug Evaluation and Research, and Kenneth Seamon, associate director for research at FDA's biologics center. The first task of the committee will be to develop criteria for assessing CDRH's research activities and design the actual review process. The program review is expected to be completed and recommendations for changes made by October. Although the OST program review seeks to more closely align CDRH research with pre- and post-market activities, the project is not likely to result in the permanent transfer of OST staffers to ODE, FDAers say. The permanent transfer of research staff to the device evaluation program was recommended in the recent House Energy and Commerce oversight subcommittee report on CDRH ("The Gray Sheet" June 7, p. 6). Although OST staffers will continue to assist in review of device submissions on a temporary basis, their permanent transfer to ODE would not be practical because OST resources are stretched too thin, according to device center staffers. OST is losing roughly 40 people with the transfer of the division of biometrics sciences to the new office of surveillance and biometrics (see related item, In Brief).
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