(Image by Matt Duncan on Unsplash)
The FDA has mapped out how it plans to catch up on pandemic-delayed facility inspections — including 2,426 medtech inspections.
In a new report called Resiliency Roadmap for FDA Inspectional Oversight, the agency said it will prioritize inspections in terms of urgency and the threat posed by COVID-19 domestically and abroad.
The FDA had planned to inspect nearly 21,000 establishments across all the commodities it regulates — human and animal drugs, medical devices, radiological health facilities, biologics, biological research monitoring and tobacco — in its fiscal 2020, which ended Sept. 30. Before the onset of the pandemic, it only got to 13,000 of them, including those of medical device facilities conducted by other countries’ regulators under the Medical Device Single Audit Program.
Now the agency says it plans to conduct a total of 26,250 surveillance inspections in FY21, including any remaining surveillance inspections postponed from the previous fiscal year. As of March 2021, the agency had inspected 2,953 of these facilities.
In the report, the agency outlines three scenarios for proceeding, with the best-case scenario having it resume normal inspection operations this month and base-case or average scenario postponing normal operations until mid-summer. Worst-case scenario plans would revert to more restrictive pandemic operations.
“FDA recognizes the overall challenge presented by the volume of surveillance work, particularly related to lower-risk inspections that are nevertheless mandated to occur at certain frequencies,” the agency report said. “We will be exploring ways to manage this challenge moving forward.”
