FDA finds early success with a new system to track its import evaluations
A new system the Food and Drug Administration is using to track its review of imports into the United States is finding some early success increasing productivity.
The mobile and web-based application known as System for Entry Review and Import Operation, or SERIO, replaces a decades-old system and has contributed to a 10% increase in the number of products evaluated and a 9% increase in compliance actions taken, the FDA told FedScoop.
Investigations of imports are a cornerstone of the FDA’s regulatory responsibility to ensure food and drug products brought into the country compliant with U.S. requirements. The program is essential for preventing harmful products from reaching American consumers.
A key part of SERIO is that the investigators can use it in the field, John Verbeten, deputy director for import operations enforcement in the FDA Office of Regulatory Affairs, said in an interview with FedScoop.
“The system that we had before couldn’t be supported on the mobile devices,” Verbeten said. “And so you’re still stuck with having to go back to the office with all of your information, and then record the work that you did.”
He added: “Now, you’re doing this stuff real-time.”
Most entries into the U.S. are processed and admitted into the country through an existing system called PREDICT, but Verbeten estimated roughly a quarter of the more than 50 million lines of FDA-regulated product imported last year still need human intervention. That’s where investigators come in to assess compliance, including evaluations in the field.
The SERIO application, which the agency is developing with contractor REI Systems, allows those investigators to do things like upload a photo or reference information about an appropriate sample size while in the field using a tablet or laptop. Previously, Verbeten said, investigators had to add photos later or bring reference information along with them.
“It provides for more contemporaneous a collection of information or evidence and just helps speed along that process,” Verbeten said.
Industry recently took notice of the project when the team responsible for the implementation of the new system was recently recognized by AFCEA Bethesda, a nonprofit civilian chapter of an organization focused on technology in government, as “IT Modernization Innovation Leader of the Year.”
The efficiency of evaluations has become increasingly important amid rising number of imports, including food, drugs, devices, and cosmetics. Over the last decade, the volume of total lines of product imported into the country has risen by about 84%, according to FDA data.
The investigations portion of SERIO is part of a broader effort to replace functionalities of system the agency has been using since the late 90s called the Operational and Administrative System for Import Support (OASIS), according to Gregory Parcover, director of division of imports systems solutions in the Office of Information Systems Management at ORA.
That older system “is built on aging technology,” Parcover said in an emailed statement.
“Building a new system on more modern technology allows us to enhance the system in ways that can improve the user experience as well as improving efficiency by making the system quicker and more intuitive to use,” Parcover said.
The FDA began developing SERIO in fiscal year 2017, and while the investigations part of the system is in use now, other aspects are forthcoming. A system for the regulatory affairs office’s compliance team, for example, is still in the works.
Verbeten called the system a “great tool” for the investigators in his office who he said are “out there every day promoting and protecting the public health, doing all sorts of things that people generally don’t know about and don’t see to keep our country safe.”
