On May 31, the FDA Center for Devices and Radiological Health (CDRH) announced that, as of June 1, 2022, CDRH plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions. Though the agency notes that due to the continued elevated workload related to COVID, it’s likely these IVD pre-submissions will initially be reviewed under an extended timeline.
The announcement from Jeff Shuren, MD, JD, director of CDRH, and William Maisel, MD, MPH, director, Office of Product Evaluation and Quality, CDRH, highlights the impact of the COVID-19 pandemic, during which the agency received an “unprecedented number” of emergency use authorization (EUA) requests and pre-EUA submissions for COVID-19 tests and collection kits.
These COVID-related devices were given priority, meaning that the CDRH was not able to review some non-COVID IVD pre-submissions. “Our IVD office has focused on increasing staffing to address the increased volume of work, allowing us to provide more resources to our conventional premarket workload… We are pleased to announce that, as of June 1, 2022, CDRH plans to accept all non-COVID IVD pre-submissions. Due to the continued elevated workload related to COVID, it’s likely these IVD pre-submissions will initially be reviewed under an extended timeline,” the statement reads.
As CDRH returns to normal operations, it also is considering withdrawing its guidance, “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers (Revised)” to allow sponsors adversely impacted by the pandemic more time to address submission deficiencies.
Related Articles
-
The FDA has updated the CDRH portal to allow users to track the progress of their pre-submissions. As of October 23, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using FDA’s eSTAR portal.
-
Unhappy with current textbooks and resources for regulatory professionals, Elijah Wreh, Professor of Regulatory Science and Senior Manager Regulatory Affairs at Boston Scientific, authored his own book for industry and future regulators.
-
Effective February 7, the agency will conduct inspections across all commodities, as well as mission-critical foreign and domestic inspections.
-
The CERSI program was established to foster robust and innovative approaches to advance regulatory science through collaborative interactions with FDA scientific experts.
