FDA Commissioner Marty Makary [Photo courtesy of the FDA]
Artificial intelligence will help identify low-risk facilities for the one-day assessments, FDA Commissioner Marty Makary said on Wednesday at the Food and Drug Law Institute Annual Conference in Washington, D.C.
The agency said the pilot is part of a broader initiative to evaluate more facilities and gather insights with more efficient and targeted inspections without sacrificing regulatory rigor. These one-day assessments are intended to complement the FDA’s existing approach to standard inspections, not replace standard assessments, the FDA said.
“The idea is we can do more inspections,” Makary said in Washington, D.C.
Data gathered through the one-day assessments could be used to identify recurring compliance themes, manufacturing facility-specific risk scores, discrepancies in the facility’s registered operations, leading to more targeted future oversight actions, the agency said.
Related: FDA, CMS unveil accelerated Medicare coverage pathway for breakthrough devices
“For the FDA, the ability to conduct shorter, targeted assessments allows for broader surveillance coverage, enabling the agency to assess more facilities and gather critical insights without compromising regulatory rigor,” Makary said in a news release. “For industry, these assessments can provide timely feedback while minimizing operational disruption, particularly for lower-risk establishments.”
The one-day screening assessments began in late April across select medical products, biologics, human and animal foods and clinical research facilities. Facilities are selected using risk-based criteria such as product type, prior inspection outcomes and operational characteristics, the FDA said.
The FDA said it has completed 46 one-day assessments, with most assessments successfully confirming compliance and earning the agency’s “No Action Indicated” (NAI) inspection classification.
Investigators have the authority to expand the scope or duration of an assessment if warranted, the agency said. Some of those 46 inspections completed extended beyond one day when significant observations were identified, the FDA said.
FDA said the pilot will continue through fiscal 2026 as it continues developing metrics to assess effectiveness.
“We are closely analyzing the operational and compliance data from these assessments — including trends in outcomes, risk signals, and investigator feedback to determine how this approach can enhance our broader inspectional strategy,” said FDA Inspections and Investigations Associate Commissioner Elizabeth Miller.
