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 Discover how scientists and engineers in the Office of Science and Engineering Laboratories (OSEL) at the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) promote innovation for the development of new lifesaving medical devices.
2022 Regulatory Science Tools Webinar Series
The National Institutes of Health's (NIH) National Heart, Lung, and Blood Institute's (NHLBI's) Small Business Program is partnering with CDRH for a free webinar series examining medical device innovation with regulatory science tools. Part three of the webinar series will focus on Computational Modeling Tools – Evaluating the Safety and Performance of Blood-Contacting Medical Devices.
Who should attend:
- Entrepreneurs
- Small business innovators who are interested in using regulatory science tools for emerging technologies
Hear from distinguished leaders in the small business and medtech innovation space including NHLBI, CDRH, and the NIH's Small business Education and Entrepreneurial Development (SEED) office.
Date: March 16, 2022
Time: 2:00PM ET - 3:00PM ET
OSEL Program Highlights
Job Opportunities
Interested in a science or engineering career at the heart of public health and medical device innovation? CDRH's OSEL has openings for candidates with a strong background in a variety of scientific disciplines, including laboratory research policy or consulting support for reviews of new medical devices, and analysis of device failures.
Read more and apply today at Job Opportunities at OSEL.
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Chemical Characterization and Non-targeted Analysis of Medical Device Extracts
Developers of medical devices evaluate the biocompatibility of their devices prior to the FDA's review and before introduction of the device to the market. Chemical characterization is an alternative approach for addressing some biocompatibility endpoints, and extractables testing is one approach to chemical characterization.
In this article, we describe the elements of extractables studies and provide an overview of the current practices, identified gaps, and emerging practices that may be adopted on a wider scale in the future. This article follows the steps of an extractables study: information gathering, extraction, extract sample processing, system selection, qualification, quantification, and identification.
Read the journal article in American Chemical Society (ACS) Biomaterials Science & Engineering
Contact OSEL
If you have questions about OSEL, email OSEL_CDRH@fda.hhs.gov.
You can also subscribe to CDRH Science for regular email updates on CDRH's scientific topics and OSEL.
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