ViiiClassification of Medical Products

The issue of how to classify various nanotechnology products arises in deciding which of the different centers has jurisdiction over the product. The determination can be critically important in defining the scope of regulation that a particular product is subject to because of the different approaches taken by the different centers. Of course, the classification system used by the FDA reflects the division of the centers as described above. Without forgetting that the FDA regulates other products also, a discussion of the classification issues may usefully begin by considering the different classifications of medical products: drugs, devices, biologics, and combination products. The first three of these have been discussed, but "combination products" perhaps deserve some additional comment. Basically, a combination product is exactly what the term suggests—it is some product that has multiple components that fall within more than one of the other classifications: combination products are drug + device, drug + biologic, device + biologic, or drug + device + biologic.

Essentially, classification of a product as a "drug" means that it will be regulated by the CDER; classification as a "device" means it will be regulated by the CDRH, and classification as a "biologic" means it will be regulated by the CBER. When a product is a combination product, it is the "primary mode of action" of the product that governs. This means that the manner in which a combination product is regulated may very well hinge on what is determined to be its "primary mode of action." A drug-device combination product could potentially be regulated according to the requirements of the CDER or the CDRH.

The classification of combination products is a relatively recent development at the FDA, perhaps reflecting the fact that the original classifications of drug, device, and biologic were by themselves insufficiently flexible to accommodate various technical advances that blurred these distinctions.

The classification of "combination product" was created by Congress in 1990 and separate (two-way) agreements between the different centers were established to simplify determination of the primary mode of action and assignment to the correct center. But even so, there have been a number of controversies over jurisdictional assignments of combination products, not only initiated by manufacturers of the products but also initiated by one or more of the centers themselves. In 2003, an Office of Combination Products was established to make the assignments and to resolve disputes. It is generally expected that this office will improve the effectiveness of the assignments of combination products to specific centers.

What is interesting about nanotechnology is that it very naturally blurs some of the bases for distinguishing between the different classifications, which were developed from macroscopic properties and behaviors. When considering the manipulation of matter at the microscopic level, what distinguishes a "drug" from a "biologic"? And in what way are the intrinsic chemical interactions between matter at that level distinct from its manipulation with a "device"? These are questions that currently have no clear answer, and yet the specific regulations that will govern the use of nanotechnology very much depend on how specific products are to be classified.

The FDA has recognized the challenges involved with regulating nano-technology and initiated a number of concrete steps to address them. In particular, the FDA actively participates in a number of committees and working groups, including the Nanoscale Science and Engineering Technology (NSET) Subcommittee of the National Science and Technology Council Committee on Technology. It is a cochair of the NSET Working Group on Nanomaterials Environmental and Health Implications, which works to define methods for testing and evaluating the safety of nanotech products. It also participates in programs run by the National Institute of Environmental Health Sciences and the National Toxicology Program to evaluate the toxic-ity of nanomaterials.19

In addition to participation with these external groups, the FDA has a number of internal efforts directed at ensuring that it is well informed about nanotechnology issues and in a position to promulgate regulations that are meaningful. Perhaps foremost of these internal efforts is the formation of the Nanotechnology Task Force in August 2006. This task force is "charged with determining regulatory approaches that encourage the continued development of innovative, safe and effective FDA-regulated products that use nano-technology materials."20 The mandate of the task force is relatively broad, requiring that it hold a public meeting and engage in a process that assesses the current state of scientific understanding of nanotechnology and both to evaluate the effectiveness of existing regulatory approaches and to explore how nanotechnology might be used in developing safer products.

In addition to this task force, the individual centers and the Office of the Commissioner engage in efforts to familiarize those employed by the agency with issues related to nanotechnology. For instance, the CDER has a

Nanotechnology Working Group that seeks to develop a better understanding of how nanotechnology impacts regulatory issues within its group. In addition, the Office of Science and Health Coordination, which is a part of the Office of the Commissioner, helps to coordinate a variety of discussions within the agency, some of which relate to nanotechnology.

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