Introduction

Return to the Table of Contents.

The Center for Devices and Radiological Health (CDRH) maintains a variety of basic programmatic tools to accomplish its mission: the promotion of public health through responsible regulation of medical devices and radiation-emitting products. One of these basic tools is an intramural science program in CDRH's Office of Science and Technology (OST), covering key areas of engineering, physics, biology, and computer sciences.

ROLE OF OST

OST serves several functions in CDRH. These functions are realized through a range of specific operational activities. The tangible accomplishments of OST's activities include the laboratory evaluation of products, the development and validation of test methods and measurement techniques, risk assessments and hazard analyses, characterizations of the key use-conditions of regulated products, development of generic techniques to enhance product safety and usefulness, and technical consultations for a wide variety of CDRH purposes. OST also has direct involvement in the review of regulatory documents. All of these activities are represented in the project descriptions that follow in this report.

SCOPE OF THE REPORT

This report describes the Office's major scientific projects and reflects their status as of September 30, 1996. These may be of a laboratory, computational, or analytic nature. In addition to such projects, OST scientists are routinely involved in the review of regulatory documents (e.g., manufacturers' submissions for premarket approval), and the development of regulatory decisions (e.g., health hazard evaluations for enforcement decisions). In general, this report does not cover such routine contributions made by OST staff to the regulatory review process except insofar as those activities are related to technical projects. Finally, the consensus standards activities that are described here comprise only those areas in which substantial progress was manifest in this year. OST staff members are involved in numerous other standard committees (see appendix G).

ORGANIZATION OF THE REPORT

Premarket evaluation activities are those which are oriented toward the development of information to assist CDRH in assessing the safety and effectiveness of products presently being submitted for approval. Analogously, enforcement projects are associated with regulatory actions related to products already on the market, including the enforcement of mandatory performance standards promulgated under the Radiation Control for Health and Safety Act.

Postmarket surveillance projects encompass major new initiatives for a class of Postmarket Studies mandated by the Safe Medical Devices Act, and a variety of other efforts to monitor the performance of devices in current use. Consensus standards projects are efforts undertaken to foster international harmonization, or to codify test methods and performance criteria in support of CDRH regulatory programs.

Proactive projects are OST-initiated and of an anticipatory nature: exploration of suspected hazards (which may necessitate regulatory action); development of tools to facilitate regulatory decisions for emerging products that have not yet arrived at CDRH for action; or leveraged public health projects developing generic techniques to improve performance of broad categories of devices. As shown in the table on the next page, most projects are motivated by more than one of these goals.

Table 1. OST Project Areas