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U.S. Department of Health and Human Services

About FDA

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Laboratory of Active Materials

Laboratory leader: Dave Saylor 301-796-2626 david.saylor@fda.hhs.gov

Scientists in the Active Materials Laboratory investigate materials used in devices in which the time dependence of materials properties is a key component of how the device's mode of action is provided. This includes combination products in which medical devices incorporate some material-based mechanism for drug delivery, such as drug eluting stents. It also includes nano-materials, in which the properties of the nano-particles are critical to delivery of the resulting medical treatment. 

To evaluate these types of medical devices, scientists in the Active Materials Laboratory have developed the following research approach:

  1. Theory and Computation: Theoretical modeling methods were develop that can create a microscopic image of the materials’ structures which allows researches to then predict rates of drug release from medical devices or silver ion release from nanoparticles.
  2. Manufacturing and Morphology: Nanoparticles or controlled release surrogate systems are manufactured, and the structure and properties of the nanoparticles or drug dispersed in the medical device is studied by microscopy. This is then correlated to the theory and computation.
  3. Release of drug or ions: The drug or silver ion release from the manufactured controlled release surrogate systems is measured to predict its tissue concentration. These results are correlated to the microscopy and computation results to better understand the mechanisms of action of the effect of processing variation and materials structure/chemistry on release.