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Top FDA Official: Agency ‘Creative,’ ‘Efficient,’ ‘Focused’ After COVID-19 Domestic Inspection Hiatus

Top FDA Official: Agency ‘Creative,’ ‘Efficient,’ ‘Focused’ After COVID-19 Domestic Inspection Hiatus

Source : Medtech Insight

A top US Food and Drug Administration official says the agency is being “very creative” and “efficient” as it sends its inspectorate back into the field to conduct on-site routine surveillance inspections following a four-month hiatus.

The FDA stopped performing inspections in March at manufacturing facilities in the US and abroad. The agency resumed domestic audits on 20 July, but only in areas of the country where the COVID-19 pandemic allows (among other caveats). ("FDA Wants To Restart Domestic On-Site Inspections On July 20 But There Are Caveats" "Medtech Insight" )

William Maisel, director of the Office of Product Evaluation and Quality within the FDA’s Center for Devices and Radiological Health, said the safety of the agency’s investigators and the people working at inspected companies is of paramount importance.

The FDA’s Office of Regulatory Affairs, which conducts all of the agency’s field activities, has been “very creative in trying to make sure that their inspections are efficient, focused, and minimize any risks to either their inspectors or to the company being inspected,” Maisel said on 15 September at RAPS Convergence 2020, hosted by the Regulatory Affairs Professionals Society.

He noted that the device center has been leaning on “paper reviews of documents where those types of reviews can suffice for the information that’s needed, whether it be for PMA approval for a company that we’re very familiar with and have inspected in the past, or whether it be for a company that has particular issues or concerns that we’re following up on.”

As for the future, Maisel is counting on a “transition back to normalcy” for facility inspections – “but what that timeline looks like, I think really hasn’t yet been established.” 

By Shawn M. Schmitt