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US FDA discusses impact of COVID-19 pandemic on CDRH and how it is prioritizing workload moving forward

May 01, 2021

US FDA has issued a review A Year into the Pandemic: How the FDA’s Center for Devices and Radiological Health is Prioritizing its Workload and Looking Ahead. Below is a summary of the key messages.

  • Premarket submissions for devices and combination products that the Food and Drug Administration (FDA or “the Agency”) regulates as devices increased by 38% in 2020 due to the Agency’s receipt of 5,500 Emergency Use Authorization (EUA) and pre-EUA submissions for products related to COVID-19 and more (17,000 total) 510(k) premarket notifications, de novo requests, humanitarian device exemptions (HDEs), premarket approval applications (PMAS), and pre-submissions.
  • Moving forward, the Center for Devices and Radiological Health (CDRH) will continue to prioritize work related to COVID-19, including the review of premarket submissions, the issuance of policies and guidance documents, and enforcement actions.
  • Review times for device premarket submissions for non-COVID-19 in vitro diagnostics (IVDs) are longer than normal (the Agency did not identify the “normal” or current review times for those types of devices). In the next eight weeks, FDA expects to eliminate delays in the initiation of the Agency’s review of submissions for non-COVID-19 IVDs. In addition, FDA will provide applicants with name and contact information for their lead reviewer and projected review times within 30 days of FDA’s receipt of non-COVID-19 submissions.
  • For the remainder of the year, FDA will accept pre-submissions for IVDs only if they pertain to COVID-19, are companion diagnostics, involve a breakthrough designation request, or have a significant public health impact.
  • Review times for pre-submissions to the Divisions in the Agency that regulate personal protective equipment (e.g. respirators, facemasks, gowns, and gloves), ventilators and general hospital equipment are expected to increase from 70 days to 120 days.
  • FDA expects to continue to meet its target review times for premarket submissions and pre-submissions for other types of device-led vs. device-lead combination products, but there will be exceptions.

To read the full article from the FDA, click here.

Further, FDA’s recently-issued Quarterly Device User Fee Performance Report provides more detailed statistics for each type of premarket submission, as well as pre-submissions and investigational device exemption (IDE) applications, through December 31, 2020.

How TSG can help

TSG’s Medical Device Regulatory Consulting team has the experience to guide you through the FDA’s regulation of medical devices.

If you need help finding or interpreting information in the Quarterly Device User Fee Performance Report, or need assistance in bringing your product to market, contact us at [email protected]