FDA Regulation on Nanotech Products

Monday, February 27, 2006

This FDA policy may be adequate in covering nanoscale products, however, a new regulation would certainly be required to cover nanomedicines in the future.

The FDA paradigm for regulation of these products is based on the concepts of "risk management", i.e. risk identification, risk analysis, and risk control. To implement risk management for nanotechnology products, we must acknowledge that the cells and molecules with which FDAers work every day are "nano" in size. In particular, every degradable medical device or injectable pharmaceutical generates particulates that pass through this size range during the processes of their absorption by the body. FDA has not experienced an adverse reaction related to the "nano" size of resorbable drug or medical device products.

FDA regulates on a "product-by-product" basis. Although the several pieces of enabling legislation have established several formalisms for regulation with different names for each product type, they all basically fall into three categories: Premarket Approval, Premarket "Acceptance" and Post Market Surveillance.

  • Premarket Approval -- This process is that with which most people believe they are familiar. Prior to introduction into the marketplace, new pharmaceuticals, high-risk medical devices, food additives, colors, and biologicals require approval by FDA.
  • Premarket "Acceptance" -- In this general category are several similar authorities. For example, pharmaceuticals that are manufactured to existing USP Monographs and medical devices marketed with 510(k) Premarket Notifications. The review process of these products is significantly more rapid than Pre-Market Approval.
  • Post Market Surveillance -- In this third category, FDA manages the risks of products like foods, cosmetics, radiation emitting electronic products, and materials such as food additives and food packaging that are "generally recognized as safe" (GRAS). For these products, market entry and distribution are at the discretion of the manufacturer/producer. All these products are generally regulated by the application of Good Manufacturing Practices. FDA monitors the behavior of these products and takes regulatory action if adverse events occur that threaten public or individual health.

FDA expects many nanotechnology products that we regulate to span the regulatory boundaries between pharmaceuticals, medical devices and biologicals. These will be regulated as "Combination Products" for which the regulatory pathway has been established by statute. In such cases, FDA will determine the "primary" mode of action of the product. This decision will determine the regulatory framework for the product, i.e. a drug, medical device or biological product. The product application will be managed by the appropriate FDA Center with consultations from the other Centers. It is valuable to repeat here that FDA has traditionally regulated many products with particulate materials in this size range. FDA believes that the existing battery of pharmacotoxicity tests is probably adequate for most nanotechnology products that we will regulate. Particle size is not the issue. As new toxicological risks that derive from the new materials and/or new conformations of existing materials are identified, new tests will be required.

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