FDA set to resume regular imaging site inspections beginning July 20

The Food and Drug Administration is set to resume imaging site inspections, on hold since the beginning of the pandemic, next week, authorities announced Friday.

In a statement, FDA Commissioner Stephen Hahn, MD, said the administration has continued conducting “mission critical” visits through remote assessments and other methods since March. But as officials begin to ramp up regular in-person inspections once again, they’ll make use of new safety measurements. The “COVID-19 Advisory Rating,” as it’s called, will calculate each state’s readiness based on their current pandemic response phase, along with real-time infection trends. Contracted state examiners will also utilize the new ratings, officials noted.  

“At this time, we are working toward the goal of restarting on-site inspections during the week of July 20. However, resuming prioritized domestic inspections will depend on the data about the virus’ trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments,” Hahn advised. “In order to move to the next phase, we must see downward trends in new cases of COVID-19 and hospitalizations in a given area,” he added.

Other details, such as public transportation, will also influence into the decision. “The availability of these services will be an important factor in how we determine resuming domestic inspections,” Hahn noted.

For the foreseeable future, the administration plans to pre-announce all visits to help providers prepare. Hahn emphasized that safety is of the “utmost importance” to the FDA, with all investigators outfitted in personal protective equipment.

As of July 1, there are 8,676 imaging facilities certified under the Mammography Quality Standards Act and 21,890 accredited units. The FDA had performed 3,726 inspections of such facilities as of this month, according to recently released data.