fbpx Skip to main content

Subscribe to Biocom California’s Life Science Public Policy Newsletter

FDA’s IVD Submission Delay Continues

  • 2021-06-17T15:00:00.000+0000
  • Author: Izzie Omer

Dr. Timothy Stenzel, Director of the Office of In Vitro Diagnostics and Radiological Health, also referred to as Office of Health Technology 7 (OHT7), recently noted that that staff redirected toward OHT7 to support the surge of emergency use authorizations (EUAs) has returned to their original offices, leaving the team with lower levels of staffing.

While most of FDA has stayed on track with submission and approval deadlines laid out in MDUFA/PDUFA during the pandemic, the diagnostics review timeline has suffered. This is due to the high volume of EUA submissions that the agency received throughout the past year; the vast majority of which falls under the Office of In Vitro Diagnostics and Radiological Health. OHT7 is also declining IVD pre-submission requests that are not COVID-related through the end of 2021, which FDA has never done before.

FDA hosts a weekly Virtual Town Hall Series on Coronavirus (COVID-19) Test Development and Validation. On June 2, Dr. Stenzel provided an update on what his team is prioritizing. Dr. Stenzel said his office continues to receive a significant number of applications every week, totally around 160 to 200 applications a month. OHT7 will continue to only review submissions related to COVID-19, companion diagnostics, breakthrough designation requests, or products that have a significant public health impact. The team will decline other presubmission requests.