Mansfield hopes that additional guidance on topics like harmonization of FDA and CLIA requirements under the FDA LDT guidance will be available to the public soon. She felt that there were some interesting new proposals for solutions at the recent two-day public workshop, but that too many participants echoed the same misconceptions about the FDA's proposals again and again. The interviewer asked several questions about medical directors pointing doctors to innovative off label tests (or improvements, such as new mutations), and whether this clashed with "off label promoting." Mansfield noting that the issue was not new for LDTs, but exists as well for kit tests. Mansfield emphasized that at the upcoming February 20, 2015, public workshop on NGS regulation, the FDA wants to focus on innovative oversight that won't stifle rapid advances.
Further details here.
