The FDA is monitoring Covid-19 cases and hospitalisations across the US to determine places which will be safe to resume on-site inspections in
The FDA regulates medical devices and technologies - as well as drug and food products - in the US (Credit: Michael J Ermarth/FDA)
The US FDA (Food and Drug Administration) has announced plans to resume on-site, domestic inspections from 20 July.
For the foreseeable future, all inspections will also be pre-announced to FDA-regulated businesses to help create the safest possible environment for both investigators, and employees.
The FDA, which postponed domestic inspections in March due to the Covid-19 pandemic, added that this resumption will depend on how prevalent the virus is in the state or local area at the time.
To the next phase, the regulator said it must see downward trends in new Covid-19 cases and hospitalisations, adding that other services curtailed by the crisis, such as public transport, will also impact its ability to resume normal inspection activities.
In a statement, Dr Stephen M Hahn, FDA commissioner of food and drugs, said: “The health, safety and well-being of our investigators, as well as the public, are of the utmost importance to us.
“We will ensure our investigators are outfitted with personal protective equipment and are equipped with other necessary equipment to carry out their work while adhering to state and local guidance, as well as applicable CDC [Centers for Disease Control and Prevention] guidance.
“We will continue to work to ensure our prioritised domestic inspections resume appropriately and as safely as possible.”
Resumption of on-site FDA inspections
The FDA said it has continued to conduct “mission-critical inspections” and other activities over the past few months, and has been trying to determine the most appropriate time to resume other prioritised domestic inspections ever since postponement was announced on 18 March.
The regulatory body also claimed to have had “great success” using tools including remote assessments and import alerts over this period.
“As the Covid-19 pandemic continued, we adjusted our processes and guidance as necessary to maintain the appropriate level of review to ensure the safety of consumer products, including hand sanitiser, diagnostic tests and more,” said Hahn.
“At the same time, we have been closely monitoring reopening criteria established at the federal, state or county levels and planning to identify when and where to resume domestic inspections, prioritising the inspections based on risk and other factors.”
The FDA has also developed a Covid-19 Advisory Rating System to help it determine when and where it is safest to conduct domestic inspections.
The system uses real-time data to qualitatively assess the number of coronavirus cases in a local area – based on both state and national data – and comes up with a rating based on three metrics: Phase of the State, as defined by White House guidelines, statistics measured at the county level to gauge the current trend, and intensity of infection.