OST MISSION AND FOCUS

Mission

The mission of the Office of Science and Technology (OST) is to provide independent laboratory information for regulatory and other public health activities of the Center for Devices and Radiological Health (CDRH). OST accomplishes this mission by:

• anticipating the impact of technology on the safety, effectiveness and use of regulated products, through focused laboratory research;
• developing data needed for current and future regulatory problems through forensic research and testing;
• performing laboratory based evaluations and analyses in technical support of CDRH premarket and postmarket activities; and
• managing, developing and supporting standards used for regulatory assessments.

OST provides CDRH and FDA with:

INDEPENDENCE: OST provides unbiased laboratory data and analysis for CDRH regulatory decisions to compare to similar data developed by manufacturers, etc.

INFLUENCE: OST uses the scientific data and analysis from the laboratories to impact the manufacturing, standards development, and medical communities.

PROACTIVE EVALUATION: OST identifies issues and seeks laboratory solutions to emerging regulatory and public health problems.

EXPERTISE: OST experts provide a capability-in-place, available for consultation on agency issues as needed.

FORENSIC CAPABILITY: OST has available measurement capability which can be used by the Center/Agency to understand the causes of failure of regulated products.

Laboratory Focus Areas

The OST laboratory program is focused into four cross-cutting areas:

• Performance - measuring how well the device performs its intended function.
• Characterization - measuring those phenomena that contribute to degraded.
• Bioeffects - measuring the effects of a device or breakdown components of a device on body functions, i.e., "adverse effects."
• Metrology - measurement methodology development and implementation.

Scope of the Report

This report describes the Offices major scientific projects and reflects their status as of September 30, 1997. 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).

[Home] [Previous] [Next] [Comments]