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.

OSEL Program Highlights

Medical Device Material Safety Summaries: 8 New Reports

The U.S. Food and Drug Administration (FDA) partnered with ECRI (originally founded as Emergency Care Research Institute), an independent nonprofit organization, to perform a comprehensive literature search and systematic review to identify the current state of knowledge about medical device material performance after implantation.

8 new safety summaries are now available:

• Cyanoacrylates
• Hyaluronic Acid (HA)
• Nitinol
• Poly (2-Hydroxyethyl Methacrylate) (pHEMA)
• Polycaprolactone (PCL)
• Polyether ether ketone (PEEK)
• Polymethyl methacrylate
• Polytetrafluoroethylene (PTFE)

Read more about the Medical Device Material Safety Summaries.

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 partnered with CDRH for a free webinar series examining medical device innovation with regulatory science tools. The webinar recordings are now available:

• Part 1: NHLBI-FDA Regulatory Science Tools Webinar
• Part II: Phantoms Tools – The Photoacoustic Imaging Phantom Case
• Part III: Computational Modeling Tools – Evaluating the Safety and Performance of Blood-Contacting Medical Devices

Read more about the Catalog of Regulatory Science Tools.

Catalog of Regulatory Science Tools to Help Assess New Medical Devices

The Catalog of Regulatory Science Tools collates a variety of regulatory science tools that CDRH’s OSEL developed, with new tools added as they become available. We’ve streamlined the list of tools to make it easier to find and search for tools, including: Phantoms (physical and virtual) Methods (lab methods and clinical outcome assessments) Computational models and simulations (models and datasets)   Browse the Catalog of Regulatory Science Tools. Read more about Medical Device Regulatory Science Research Programs.

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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