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OSEL - Office of Science and Engineering Laboratories
Office of Science and Engineering Laboratories > Science and Engineering Divisions > Division of Chemistry and Materials Science - Overview

Division of Chemistry and Materials Sciences

Director: Dr. Steven K. Pollack
Research Staff Contacts:
Program Support Assistant: Aquila Edwards
OSEL Staff Matrix

[Overview] [ Research] [People]

graphicOverview

About the Division

The Division of Chemistry and Materials Science (DCMS) conducts research, testing, and evaluation focused on chemical and materials issues related to safety and total product life cycle (TPLC) of medical devices and their impact on public health. Inorganic and organic materials are the building blocks of medical devices; therefore, chemistry and materials issues become the focal points of this Division's research and regulatory support activities. The Division's capabilities in materials research will help the agency make regulatory decisions based on scientific and engineering expertise and the collection of independent laboratory data. The new division was established to provide the Center for Devices and Radiological Health (CDRH) and other FDA centers with the expertise and knowledge required for making scientific, engineering, and regulatory recommendations concerning the evaluation and testing of materials (synthetic and natural) suitable for medical device applications.

 

Mission

DCMS supports the scientific and engineering basis for making the regulatory decisions through the development of independent laboratory data and information on materials characterization, materials degradation, and materials-tissue interactions contributing to the public health activities of the CDRH and the FDA

Goals

1) Contributing targeted scientific expertise for decision making through the development and application of materials science and interaction expertise.

(2) Providing CDRH with independent materials science data supporting pre-market and compliance analysis.

(3) Addressing materials science issues throughout TPLC - elucidating the underlying mechanisms and development of reliable test methods.

Activities:

Mission-Oriented Science Activities

Relevant research
Test method development
Risk assessments
Forensic investigations
Product testing and evaluations
Technology analysis

Regulatory Impact Activities

PMA reviews
IDE reviews
510(k) reviews
Review of initial reports (electronic products)
Compliance actions or inspections
Guidance documents (authorship, review)
HHE committee input
Ad-Hoc committee input
Standards development and recognition

Updated May 6, 2005

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