Back in March amid the beginning of the COVID-19 pandemic, the FDA announced that in addition to postponing all international inspections, it would also be temporarily halting all domestic routine surveillance inspections. This unusual move by the agency was made to protect the health of all FDA staff and in response to the growing industry concerns about visitors to medical device facilities...

1. FDA’s Plan to Re-Start Routine Inspections
By: Madison Wheeler
Back in March amid the beginning of the COVID-19 pandemic, the FDA announced that
in addition to postponing all international inspections, it would also be temporarily halting all
domestic routine surveillance inspections. This unusual move by the agency was made to protect
the health of all FDA staff and in response to the growing industry concerns about visitors to
medical device facilities. Now that we’re halfway through May, the FDA is working with the CDC
to develop a process to re-start its inspection program; this process will follow the same criteria
outlined in the White House strategy for reopening the US economy.
In a statement from the FDA commissioner Stephen Hahn last Monday, he stated that the
process to return to on-site facility surveillance inspections will follow the same gating criteria
outlined in the White House Guidelines for Opening Up America Again.1 It will likely follow the
same phase-approach methodology and be driven by scientific data surrounding COVID-19 cases
per state. Hahn also stated that the agency’s priority and commitment are “to first protect the health
and well-being of not only our own highly skilled workforce and state contract inspectors, but also
the health of workers in the important industries we regulate.”2
While the agency works towards a cohesive strategy for beginning post-pandemic routine
inspections, it is putting heavy reliance on the self-monitoring of medical device firms. The
obvious drawback to this is that many firms are facing unprecedented obstacles in the face of
COVID-19 and may lack the capacity to comply with regulations during the pandemic. In response
to this, the FDA updated a guidance to detail how manufacturers should handle post-market
adverse event reporting during the pandemic. The updated guidance not only defines the agency’s
expectations and requirements specific to pandemic situations but also recommends the
development of a continuity of operations plan (COOP).3 In short, the agency states that adverse
event reporting processes as required by regulations should be maintained to the maximum extent
possible. If firms are unable to fulfill the requirements defined in the regulations during a
pandemic, the guidance outlines what steps should be taken.
1 CDC/White House (May2020) OpeningUp America Againretrieved on05/17/2020 from:
https://www.whitehouse.gov/openingamerica/
2 Hahn, FDA (May2020) COVID-19 Update:FDA updateson surveillance inspections during COVID-19 retrievedon 05/17/2020
from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-updates-surveillance-
inspections-during-covid-
19?utm_campaign=051120_Statement_FDA%20updates%20on%20surveillance%20inspections%20during%20COVID-
19&utm_medium=email&utm_source=Eloqua
3 FDA (May2020) Post-marketingAdverse Event Reporting for Medical Products andDietarySupplements During a Pandemic
retrieved on05/17/2020 from: https://www.fda.gov/media/72498/download

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While the agency is not quite ready to begin on-site inspections again, they are working
diligently towards a plan and an update for the industry. In the meantime, if your medical device
firm is unsure how to navigate the FDA’s expectations around inspections or adverse event
reporting during the pandemic, EMMA International is ready to help. Our team is keeping up to
date on all COVID-19 regulatory policies and are ready to help you during these unprecedented
times. Contact us at info@emmainternational.com or call 248-987-4497 to see how we can help.