Government Regulation of Nanorobots in Medicine: A Two-Part Series
PART I: The FDA's Consideration of Nanorobots
By: Jessica L.A. Marks and Shana K. Cyr, Ph.D.
Nanorobots in medicine are a fascinating development and growing industry. As of 2014, over 200 companies were pursuing commercial efforts in nanomedicine, with at least 23 in advanced development stages. The nanorobots market is expected to grow more than 6% each year until at least 2020, with the primary driver being medical use.
In Part I, we discuss regulations and guidance by the U.S. Food and Drug Administration (FDA) for moving medical nanorobot products from the laboratory to the market. In Part II, we will explore the challenges nanorobot inventions face when seeking protection at the U.S. Patent and Trademark Office (PTO).
Nanorobots and the FDA
Nanorobots are classified by the FDA based on whether the product is mechanical, chemical, or biological. The classification will determine which FDA center has jurisdiction over the product. Medical devices, having a mechanical mode of action, are regulated by the FDA's Center for Devices and Radiological Health (CDRH). Drugs, having a chemical mode of action, are regulated by the Center for Drug Evaluation and Research (CDER). And biologics, having a biological mode of action, are regulated by the Center for Biologics Evaluation and Research (CBER). If a product has more than one mode of action, it is considered a combination product, and one center is assigned primary jurisdiction for the product's review based on the product's primary mode of action. For many nanorobots, the primary mode of action may be mechanical, and the product would be regulated by the CDRH.
The problem with this schema for nanotechnologies is that they do not fit neatly into these three categories. New product sponsors can seek clarity by requesting a classification of the product by the FDA. Sponsors may increase the chances of classification in a desired category by describing the product in a manner that influences the conclusion. Once a nanorobot is classified and assigned to a lead center, its review will likely be similar to the review of any other medical product at that center.
In December 2017, the FDA released its first draft guidance that could relate to regulation of nanorobots (hereinafter, "Draft Guidance"). The Draft Guidance, released by the CDER and CBER, is directed to drug and biological products that contain nanomaterials; whether it applies to nanorobots is unclear. The Draft Guidance recognizes that the FDA does not have established definitions for the terms "nanotechnology," "nanomaterial," or "nanoscale," much less "nanorobots," and specifically avoids creating definitions. The focus of CDRH's nanotechnology program is on understanding the physico-chemical interactions of nanomaterials and on appropriately characterizing nanomaterials. Notably, the CDRH, which regulates medical devices, was not involved and has not issued any guidance documents on what is required or expected for the review of nanorobots. Information on how the CDRH will treat (or potentially is treating) such products is not available.
The Draft Guidance primarily provides a list of considerations for the evaluation of nanoscale products, but there is little in the way of hard-and-fast rules or requirements. Thus, regardless of categorization, applicants will need to consult closely with the FDA regarding the data required to obtain approval for their nanorobots.
In Part II, we'll discuss how the PTO handles these nanorobot technologies.