Considering Whether FDA-Regulated Products Involve Nanotechnology

What You Need to Know? 👇

What are the FDA’s two key points to consider when determining if a product involves nanotechnology?

FDA considers: 1) Whether a material is engineered to have at least one dimension in the nanoscale range (1-100 nm), and 2) Whether a material exhibits dimension-dependent properties or phenomena, even if dimensions fall outside nanoscale up to 1,000 nm.

Does FDA have regulatory definitions for nanotechnology terms?

No, FDA has not established regulatory definitions for “nanotechnology,” “nanomaterial,” “nanoscale,” or related terms. This guidance provides screening tools rather than regulatory definitions, with the understanding that these may evolve as scientific knowledge advances.

What does “engineered” mean in the context of nanotechnology products?

“Engineered” refers to deliberate manipulation, manufacture, or selection of materials to achieve specific dimensions or properties. This distinguishes intentionally designed nanotechnology products from naturally occurring nanoscale materials or incidental presence of nanoparticles in conventional manufacturing.

Why does FDA consider materials up to 1,000 nm instead of just the traditional 100 nm limit?

Materials can exhibit dimension-dependent properties beyond the traditional 100 nm nanoscale range. The 1,000 nm upper limit helps capture materials that may exhibit nanotechnology-related properties while excluding macro-scaled materials unlikely to be associated with nanotechnology applications.

How does FDA regulate nanotechnology products differently from conventional products?

FDA doesn’t categorically judge nanotechnology products as inherently benign or harmful. They’re regulated under existing statutory authorities using current safety assessment frameworks, with product-specific evaluations considering unique properties that nanotechnology may impart to each specific product and intended use.

When should manufacturers consult with FDA about nanotechnology products?

FDA advises industry to consult early in the development process, especially for products not subject to premarket review. This facilitates mutual understanding of scientific and regulatory issues and ensures appropriate evaluation of safety, effectiveness, and regulatory status considerations.

---

What You Need to Do 👇

Recommended Actions

1. Apply the two Points to Consider to evaluate if products involve nanotechnology:
   • Check if materials have dimensions in 1-100nm range
   • Check if materials exhibit dimension-dependent properties up to 1,000nm
2. If either point applies:
   • Evaluate safety, effectiveness and public health impact
   • Consider unique properties and behaviors
   • Assess need for specific testing approaches
3. For products requiring premarket review:
   • Submit comprehensive characterization data
   • Address potential implications of nanotechnology application
4. For products not requiring premarket review:
   • Consult FDA early in development process
   • Document evaluation of nanotechnology considerations
5. Monitor for additional FDA guidance specific to product categories
6. Consider need for modified or new testing methods to evaluate nanomaterial properties
7. Document rationale for determining whether product involves nanotechnology application

Key Considerations

Non-clinical testing

• Technical assessments should be product-specific, considering effects of nanomaterials in particular biological and mechanical contexts
• Need to consider specific tests (traditional, modified or new) to determine physicochemical properties and biological effects
• Consider routes of exposure, dosage, and behavior in biological systems

Biocompatibility

• Consider unique properties and behaviors that nanotechnology may impart
• Evaluate biological effects in specific tissues and organs
• Consider biodistribution and biological behavior

Safety

• Evaluate safety implications of unique properties exhibited by nanomaterials
• Consider altered properties or phenomena that may affect product safety
• Assess potential implications for safety that arise with application of nanotechnology

Other considerations

• Consider whether materials are deliberately engineered vs naturally occurring at nanoscale
• Evaluate both finished products and materials intended for use in finished products
• Consider properties and phenomena attributable to dimensions outside nanoscale range
• Early consultation with FDA recommended during development process

---

Relevant Guidances 🔗

• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Immunological Testing for Medical Devices: Evaluation and Assessment of Adverse Effects
• Chemical Analysis in Medical Device Biocompatibility Assessment (Draft)

Related references and norms 📂

• ISO/TS 80004-1:2010: Nanotechnologies-Vocabulary-Part 1: Core terms

---

Original guidance

• Considering Whether FDA-Regulated Products Involve Nanotechnology
• HTML / PDF
• Issue date: 2014-06-23
• Last changed date: 2019-04-20
• Status: FINAL
• Official FDA topics: Radiation-Emitting Products, Tobacco, Medical Devices, Food & Beverages, Dietary Supplements, Drugs, Animal & Veterinary, Food & Color Additives, Premarket, Biologics, Records, Cosmetics
• ReguVirta ID: fc111a20e87bd45bb6d78be315cf5707