The Nanotechnology 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 nanomaterials. This is one of 20 research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).

Nanotechnology and Medical Devices

Engineered nanomaterials have been incorporated into medical devices reviewed by the FDA. These devices include in vitro diagnostic devices, orthopedic and dental implants, wound dressings, bone void fillers, stents, vascular grafts, vascular closure devices, embolization protection devices, heart valves, catheters, and cancer therapeutics. Nanomaterial applications also include combination products, such as delivery vehicles for drugs or biologics.

Nanomaterials properties enable development of novel, tunable medical devices for enhanced tissue integration and therapeutic action (for example, antimicrobial properties and drug delivery), making them attractive candidates for use in the medical device industry. However, certain nanomaterial physicochemical properties (such as, size, surface charge, shape, stability in biological environments, and concentration) have also emerged as factors that may result in adverse cellular or tissue responses.

Regulatory Science Gaps and Challenges

Major regulatory science gaps and challenges that drive the Nanotechnology Program are:

• Difficulty in determining if the device contains nanomaterials because of lack of universal definition for nanotechnology in medical device field
• Lack of understanding of the effects of manufacturing and processing on physicochemical properties of engineered nanomaterials to support biocompatibility and safety assessments, ensure batch-to-batch consistency, and evaluate materials equivalence in medical device applications.
• Lack of reliability of some conventional biocompatibility assays used for biocompatibility and toxicity evaluation of medical devices containing nanomaterials. Some conventional assays have limitations for safety assessment of nanomaterials due to challenges including nanomaterial uptake and cellular interactions, assay incompatibility and assay interferences.

The Nanotechnology Program is intended to fill these knowledge gaps by fostering the establishment of a regulatory science knowledge base to support the FDA’s regulatory review of nanotechnology in medical devices and its impact on safety and performance.

Nanotechnology Program Activities

The Nanotechnology Program focuses on regulatory science research in these areas:

• Evaluation of appropriate physicochemical characterization critical to understand the safety and effectiveness of nanomaterials
• Assessment of manufacturing process parameters’ impact on uniformity, reproducibility, chemical impurity sterility, and biocompatibility of nanomaterials.
• Development of genotoxicity test strategy to assess safety of nanomaterials.
• Evaluation of nanomaterials/cells interaction using clinically-relevant in vitro cell models.
• Development of in vitro hemocompatibility test methods specific for nanomaterial evaluation.

For more information, email [email protected]