Imagine developing a medical device that uses a nanoscale coating, nanoparticle-based material, or engineered nanostructure to improve its performance. The technology works as intended, but during regulatory review, an important question arises.
Does the use of nanotechnology create additional regulatory considerations for the device?
The U.S. Food and Drug Administration (FDA) regulates medical devices involving nanotechnology under its existing regulatory framework. However, because materials can exhibit different physical, chemical, and biological properties at very small dimensions, FDA has developed a specific approach for identifying products that involve the application of nanotechnology.
In June 2014, FDA issued its final guidance “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.”
What Has FDA Established?
One important point manufacturers should understand is that FDA has not established a formal regulatory definition of “nanotechnology,” “nanomaterial,” or “nanoscale.”
Instead, FDA’s 2014 guidance provides two Points to Consider for determining whether a product involves the application of nanotechnology.
These considerations focus on two main questions:
- Does the product have engineered nanoscale dimensions or structures?
- Does the product exhibit properties or phenomena attributable to its dimensions?
What Are the Two FDA Points to Consider?
1. Approximately 1–100 nm
The first Point to Consider asks whether a material or end product is engineered to have:
- At least one external dimension, or
- An internal structure, or
- A surface structure
within the nanoscale range of approximately 1 to 100 nanometers (nm).
This means FDA’s consideration is not limited to the overall size of the finished medical device.
2. Dimension-Dependent Properties
The second Point to Consider goes beyond the 1–100 nm range.
FDA considers whether a material or end product is engineered to exhibit physical, chemical, or biological properties or phenomena attributable to its dimensions, even when those dimensions fall outside the approximately 1–100 nm range, up to 1,000 nm (1 micrometer).
A material being larger than 100 nm does not automatically mean that FDA’s nanotechnology considerations are irrelevant. If the material exhibits properties attributable to its dimensions, those characteristics may still warrant regulatory consideration.
Why Does Nanotechnology Matter for Medical Devices?
At very small dimensions, materials can exhibit properties that differ from those of the same material at a larger scale.
Depending on the material and application, these differences may involve:
- Physical properties
- Chemical properties
- Biological interactions
- Optical properties
- Electrical properties
- Magnetic properties
- Surface-related behavior
These characteristics can be intentionally engineered to improve the function or performance of a medical device.
However, they may also create questions related to:
- Safety
- Performance
- Quality
- Biological effects
- Public health impact
FDA therefore follows a product-focused and science-based approach, rather than automatically treating all nanotechnology products as either high-risk or low-risk.
Does Every Nanotechnology Medical Device Need Special FDA Approval?
No, FDA does not have a universal, standalone “nanotechnology approval” pathway.
A medical device involving nanotechnology is evaluated under the FDA regulatory framework applicable to that particular device.
The regulatory considerations may depend on:
- Intended use
- Technological characteristics
- Mode of action
- Safety
- Performance
- Biological effects
The 2014 guidance helps FDA and manufacturers identify when nanotechnology-related characteristics may require particular attention during product evaluation.
What Does This Mean for Medical Device Manufacturers?
For manufacturers, nanotechnology should be considered during product development, characterization, risk assessment, testing, manufacturing, and regulatory submission preparation.
Material Characterization
Manufacturers should understand the relevant characteristics of the nanomaterial, nanostructure, or finished device. Depending on the technology, this may include:
- Particle size
- Size distribution
- Shape and morphology
- Surface characteristics
- Chemical composition
- Structural characteristics
- Other relevant physicochemical properties
FDA recognizes that traditional, modified, or new testing approaches may be appropriate for characterizing physicochemical properties and biological effects associated with nanotechnology.
Need FDA 510(k) Support for Your Medical Device? – Talk to Our FDA 510(k) Experts
What About a Device That Is Larger Than 100 nm?
Being larger than 100 nm does not automatically exclude a product from FDA’s nanotechnology considerations. This is because the second Point to Consider addresses dimension-dependent properties outside the approximately 1–100 nm range, including dimensions up to 1,000 nm.
For example, a material in the several-hundred-nanometer range may still warrant consideration if its properties are attributable to its dimensions.
Therefore, manufacturers should evaluate both dimensions and properties.
Conclusion
Nanotechnology has significant potential to advance medical device innovation, but engineering materials and structures at very small dimensions can also introduce new properties and behaviors that require careful scientific evaluation.
FDA’s June 2014 final guidance does not establish a separate nanotechnology approval pathway or a formal universal definition of “nanomaterial.”
Instead, it provides two key Points to Consider: First, whether a material or end product is engineered to have at least one external dimension, or an internal or surface structure, in the approximately 1–100 nm range. Second, whether the material or end product is engineered to exhibit physical, chemical, or biological properties or phenomena attributable to its dimensions, including dimensions outside the approximately 1–100 nm range and up to 1,000 nm.
Small dimensions can create significant differences – and those differences deserve careful regulatory evaluation.
Reference
1. Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology
