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August 11, 2008

FDA Announces Public Meeting on Nanoscale Materials

Lynn L. Bergeson

In an August 7, 2008, Federal Register notice, the U.S. Food and Drug Administration (FDA) announced that it will convene a public meeting on September 8, 2008, on FDA-regulated products that may contain nanoscale materials. According to the Federal Register notice, FDA also is seeking public comments and available data “that will assist [FDA] in further implementing the recommendations of the Nanotechnology Task Force Report . . . relating to the development of agency guidances.” Written comments in response to the Federal Register notice must be received by FDA no later than October 24, 2008.

FDA states that the main objective of the public meeting “is to determine what factors [FDA] should consider in providing guidance on” the following:

  • The information and data that may be needed to demonstrate the safety and effectiveness of FDA-regulated products containing nanoscale materials; and
  • The circumstances under which a product’s regulatory status might change due to the presence or use of nanoscale materials (for example, making a device no longer exempt from [Section] 510(k) submission requirements).

Persons wishing to speak at the meeting must register and submit a presentation summary by September 2, 2008. Registration details are provided in the Federal Register notice.