Emerging Healthcare Technologies

Nanotechnology, a core piece of the GNR (Genetics – Nanotech – Robotics) revolution, requires skillful navigation of emerging and complex legal arenas, from environmental law to careful transactional strategy and drafting. Nanotechnology involves parties in the nanometer (one-billionth of a meter) world. Nanotech legal services require knowledge of many healthcare law, FDA law, and business law areas, including:

• Understanding of FDA regulation of nanotechnology
• Understanding of related FDA legal rules concerning medical devices, cosmetics, OTC products (such as sunscreens), and new dietary ingredients (NDIs) in dietary supplements
• Review of nanotech and nano-engineered rules related to labeling, production and handling
• Analysis of FTC rules relating to product advertising and substantiation of claims
• Other federal and state government regulation
• Intellectual property protection of nanotech or nanobot products
• Corporate law and corporate governance of nano-medicine companies

Our nanobot lawyers are skilled in regulatory and transactional aspects of the medical device, cosmetics, OTC drug, and healthcare and life sciences industries. We are futurists, looking forward to the integration of many sciences as humanity evolves to the next level.

Our FDA medical device and FDA cosmetics attorneys can help you understand FDA guidance documents about nanotechnology. As FDA notes:

Nanotechnology, used to make nanomaterials, allows scientists to create, explore, and manipulate materials measured in nanometers (equal to one-billionth of a meter). Such materials can have chemical, physical, and biological properties that differ from those of their larger counterparts. Importantly, properties of a material might change in ways that could affect the performance, quality, safety, and/or effectiveness, if applicable, of a product that incorporates that specific nanomaterial.

The classic FDA legal rules of adulteration and misbranding apply to nanotechnology, with special attention to the scientific and safety issues underlying nano-tech products.

Whether you are building industrial nanobots or nano-materials for assembly into other nano-machines, we will review regulatory compliance risks and advise you on bringing your nanotechnology product to market.