- FDA met all but one of the premarket review commitments it made in the MDUFA IV negotiations despite the COVID-19 pandemic disrupting its operations, according to an independent review.
- COVID-19 has dominated the attention of FDA's Center for Devices and Radiological Health since early 2020. However, while the report reveals COVID-19 has affected operations, the agency managed to meet most of its MDUFA IV commitments.
- The finding that FDA only missed the delivery of one guidance document comes as FDA and industry negotiate MDUFA V. Early talks revealed "fundamentally different" views about the program and delays to device submissions because FDA reallocated resources to COVID-19.
FDA and industry agreed to an independent assessment of premarket review in the MDUFA IV talks. Booz Allen performed the review, assessing how 11 areas have affected premarket review efficiency and performance and determining whether FDA has met the commitments it made to industry.
The main black mark against FDA in the review is its failure to publish draft guidance on "Content of Premarket Submissions for Software Contained in a Medical Device." FDA was supposed to release the draft by the end of its fiscal 2019 and finalize the text 12 months after closing the comment period as part of its digital health commitments. The agency is yet to publish the draft guidance.
However, with FDA putting the guidance on its priority list and its "overall policy and regulatory support" exceeding the MDUFA commitments, the independent reviewers gave a broadly positive assessment of the agency's digital health activities.
While FDA met its other commitments, the review also reveals areas in which COVID-19 has caused problems. The review found the pandemic affected performance of the eSTAR electronic submission template FDA began piloting in February 2020, although initial feedback from companies is said to be positive.
COVID-19 also stopped FDA staff from visiting sites to deliver an experiential learning program. The number of site visits fell from 38 in fiscal 2019, which was already down on the prior year, to five in fiscal 2020. FDA offered virtual sessions to mitigate the impact of the pandemic.
Other pandemic-related setbacks identified in the report include the pausing of some of the process improvement projects initiated by FDA to simplify its procedures. As of June, FDA had wrapped up 48 of the projects but had been forced to pause others because of the pandemic. Similarly, FDA was unable to complete all of the audits it scheduled for 2020.
FDA's ability to deliver on its MDUFA IV commitments is partly a reflection of the fact the timeframe of the review mostly covers the pre-pandemic period. With FDA remaining focused on COVID-19 this year, CDRH director Jeff Shuren has warned the agency will face challenges to "make good" on some of its MDUFA IV commitments even as it comes out the other side of the COVID-19 crisis. The warning reflects workloads that are higher than those FDA expected when it made its commitments.