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Amid the coronavirus outbreak reaching pandemic level in March, FDA stopped routine inspections of domestic and international facilities. Under the revised policy, the agency would perform inspections seen as “mission critical” while relying on off-site monitoring and the commitment of companies to quality in the absence of in-person regulatory oversight to maintain standards during the public health emergency.

Although parts of the U.S. economy are starting to reopen, the restrictions imposed by FDA in March are still in place. Hahn said the postponement of on-site inspections “will continue as local, national and international conditions warrant.”

The agency is working to get its inspection program going again, though. In partnership with CDC, Hahn and his colleagues are developing “a process that would govern how and where to return to on-site facility surveillance inspections,” the FDA commissioner said. The process will adopt the criteria for resuming activities detailed in the White House strategy for reopening the U.S. economy. 

FDA acknowledged that companies may be suffering disruptions in a guidance document updated on the same day as Hahn’s statement. The guidance details how manufacturers of all products regulated by FDA should handle postmarketing adverse event reporting if they lack the capacity to comply with regulations that are in place in normal times. 

The revised version published Monday introduces further tweaks. Throughout the text, FDA has removed references to “normal” reporting processes, replacing them with the phrase “reporting as required by statute and regulation.” 

See Full Article: FDA, CDC drawing up plan to restart routine facility inspections | MedTech Dive

Written by: Nick Paul Taylor

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