FDA Details Plan to Restart Facility Inspections

FDA recently announced that it will resume normal operations, including inspections, by July. In a report titled “Resiliency Roadmap for FDA Inspectional Oversight,” the agency detailed the challenges it’s faced during the pandemic and its priorities for carrying out inspections moving forward.

Every industry in medicine has seen immense backlogs during the crisis, but none more so than medical device makers, which according to FDA have experienced more stalled inspections than human, animal medical products and tobacco groups combined.

The agency revealed that out of the nearly 21,000 establishments it had planned to inspect in 2020, it was only able to complete 13,000 of them before the pandemic’s outset. The 8,000 inspections that were not carried out were classified as non-mission-critical.

In 2021, FDA plans to complete 26,250 surveillance inspections comprising the typical cases it sees through the year, with the addition of others rolled over from the previous year. FDA says that it will engage in 2,426 inspections under the medical device and radiological health classification.

FDA said that due to the volatility of the pandemic, including unpredictable variants, their plans for resuming inspections may be delayed or altered. The agency developed a scenario system based on a gradual transition to standard operation (base case), and immediate transition to standard operations (best case) and maintenance of an emergency-operation status (worst case).

In the base-case scenario, FDA is expected to complete only half of domestic satellite inspections before the end of the year.

The 24-page document outlines alternative tools that FDA will use for oversight and lists how FDA will prioritize inspections, noting that products for emergency use authorization will take precedence.

PM

Patrick McGuire is a BONEZONE Contributor.

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