FDA to Hold Workshop on LDTs

The Food and Drug Administration (FDA) will hold a two-day public workshop in early January to discuss its framework for regulatory oversight of lab-developed tests (LDTs). The workshop will be Jan. 8-9 at the National Institutes of Health campus in Bethesda, Md., and via webcast. Stakeholders have until Dec. 12 to register to attend the workshop. In addition, the agency said stakeholders may indicate if they want to present at the workshop’s public comment sessions during registration. The agency will begin notifying presenters with information about the time they are allotted to speak by Dec. 17. Those selected to present must submit their presentation materials by Jan. 6. According to the FDA, the deadline for submitting comments related to the workshop is Feb. 2. Draft FDA guidance documents, announced in late September and published Oct. 3 in the Federal Register, outlined a proposed LDT oversight framework and addressed notification and medical device reporting for LDTs. Comments on both documents are due Feb. 2. Details about the workshop and registration are available at http://www.fda.gov/medicaldevices/newsevents/workshopsconferences/ucm423537.htm.