ARTICLE SUMMARY:
The latest user-fee performance data underscores pandemic impact, although there might be some early signs of a turnaround.
FDA will fall short on multiple FY 2021 MDUFA performance goals, including for PMA and 510(k) reviews, newly posted data from FDA’s device center affirms.
The agency has been warning that this was likely to happen as a result of the massive COVID-19 burdens reviewers faced over the past two years, and it has spotlighted steps it is taking to turn things around. MDUFA performance data, however, is a lagging indicator, so the potential impact of those efforts wouldn’t necessarily show up in the recent data.
It does appear that the backlog of pending review decisions declined slightly at the end of 2021, which could be a positive signal. Here are few key takeaways from FDA’s February 25 quarterly MDUFA IV update to industry, which captured performance through December 31:
