Society News Archive

1 June 2015
FDA Reopens Radiation Biodosimetry Devices Comment Period for 30 Days

The Food and Drug Administration (FDA) is reopening the comment period for the notice of "Radiation Biodosimetry Devices: Draft Guidance for Industry and Food and Drug Administration Staff," which was originally published in the 30 December 2014 Federal Register. The FDA is reopening and extending the comment period on the draft to 29 June 2015, an additional 30 days.

FDA has developed this draft guidance to facilitate study designs to establish the analytical and clinical performance characteristics of radiation biodosimetry medical countermeasure devices. These devices are used to reconstruct the ionizing radiation dose received by individuals or populations using physiological, chemical, or biological markers of exposure found in humans.

A copy of the draft guidance is available for download on the website.

The text version of the Federal Register announcement is available from the U.S. Government Publishing Office.