The Materials Performance Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research to help ensure patients have access to safe and effective medical devices containing innovative materials. This is one of 20 research programs in the CDRH Office of Science and Engineering Laboratories (OSEL).
Materials Performance and Medical Devices
Medical devices are made of engineering materials like metals, ceramics, and polymers and can also incorporate pharmaceuticals and biologics. However, the synthesis, processing, and fabrication of these materials affect the physical, chemical, and mechanical properties as well as the biocompatibility of medical devices across the entire range of medical specialties. Ultimately, these factors determine whether the material is suitable for a specific application.
A medical device and its materials can also be subjected to mechanical and biochemical forces, from bearing structural loads to participating in natural metabolic cycles and enduring foreign body reactions, resulting in safety and effectiveness issues. This is the case of recent postmarket issues with metal-on-metal orthopedic implants and gynecological metal-containing implants that have raised questions about the potential for some patients to develop unexpected or heightened biological responses to the implant.
Regulatory science research that promotes the rapid innovation of safe and effective medical devices and offers technical solutions to concerns arising throughout the device lifecycle is imperative.
Regulatory Science Gaps and Challenges
The major regulatory science gaps and challenges that drive the Materials Performance Program are:
- Clinical relevance of the results obtained with methods and tools for assessing patient exposure to leachable chemicals is typically ambiguous.
- Lack of consistency of methods to assess corrosion and wear of metallic implants will not fail in vitro corrosion testing, but metal release can occur in vivo. Examples include some alloys, such as Titanium (Ti) and Cobalt-Chromium (CoCr).
- Methods for assessing performance of absorbable implants as currently the review paradigm for non-absorbable devices or ad hoc testing modifications are used to assess the performance of absorbable devices.
- Recent publications as well as postmarket reports suggest that devices (for example, pacemaker leads and polypropylene mesh) that are expected to be biostable and durable long term can lose their durability and performance during use.
- Lack of methods for assessing mechanical performance and predicting clinical performance of materials and medical devices such as medical textiles or personal protective equipment materials.
- Lack of understanding of the relations between materials, manufacturing, and final device characteristics that lead to extensive testing and burdensome regulatory process.
The Materials Performance Program is intended to fill these knowledge gaps by fostering predictable device assessment, development, and innovation and by ensuring devices perform as intended and do not unintentionally degrade or break throughout their lifetimes.
Materials Performance Program Activities
The Materials Performance Program focuses on regulatory science research in these areas:
- Facile tools that provide clinically relevant estimates of patient exposure to medical device leachables.
- Clinically relevant in vitro test methods to predict release of corrosion and wear debris from device alloys in different anatomical locations and correlate results with patient responses and outcomes.
- Clinically relevant and standardized test methods to assess the safety and performance of devices made from absorbable materials.
- In vitro test methods to assess and predict short- and long-term biochemical stability of “durable” polymers/implants.
- Methods for assessing mechanical performance of materials and medical devices that predict clinical performance.
- In vitro methods and tools to evaluate novel advanced manufacturing devices.
For more information, email OSEL_materialsperformance@fda.hhs.gov