About FDA

Laboratory of Materials Performance

Laboratory leader: Ken McDermott 301-796-2621 martin.mcdermott@fda.hhs.gov

Scientists in the Materials Performance Laboratory investigate materials used in devices in which the physical/chemical properties of a material impact its performance and the long-term behavior of these properties affect the device's safety or effectiveness. For example, the long-term performance of implanted electronic devices, such as cochlear implants or pacemakers, depends on the continued hermiticity of the devices' casings. Intraocular lenses used in cataract and other surgeries need to maintain their optical properties over time. Finally, mechanical performance and degradation of hydrogel materials, such as hyaluronic acid, may affect the safety and effectiveness of adhesion barriers and other devices.

The use of new materials and processing technologies is a challenge to the regulation of new medical devices. The knowledge gap between the Center’s understandings of existing materials used in devices evolving technologies will tend to increase the time required for the review of these submissions, as our staff "comes up to speed" in these areas. Through directed research activities, it is the goal of this laboratory to develop such expertise and insights into the behavior of new materials used in devices and the effects of manufacturing on their safety and efficacy.

Page Last Updated: 11/03/2014
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