August 5, 2010
The Food and Drug Administration (FDA) is announcing the availability for public comment of a two-volume set of documents entitled "Center for Devices and Radiological Health Preliminary Internal Evaluations," which is comprised of the preliminary reports of two internal committees: The 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. Volume I is entitled "510(k) Working Group Preliminary Report and Recommendations." Volume II is entitled "Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations." The recommendations contained in these reports are preliminary. FDA has not made any decisions on specific changes to pursue. FDA is soliciting public input on the recommendations discussed in these reports, including the feasibility of implementation and potential alternatives. Once its assessment of public input and other necessary reviews are completed, FDA will announce which improvements it will implement, as well as projected timelines for implementation.
Comments are due October 4, 2010.