How Products Flow through FDA’s Regulatory System

by: Sarah Sybert, GovernmentCIO Magazine

The Food and Drug Administration serves as a regulatory and review body for the Department of Health and Human Services to monitor new medical devices, drugs, biological products and more. To ensure safe products are available in a timely manner, especially over the past year and a half in the face of a global pandemic, the agency adapted some processes to ensure manufacturers move their product from development to distribution to meet demands.

“The industries we regulate are constantly innovating, attracting skilled professionals and upgrading their technological capabilities. The FDA must keep pace,” Janet Woodcock, FDA’s acting commissioner, wrote in a statement regarding FDA's fiscal year 2022 budget.  

COVID-19 spurred health care developers to quickly create new drugs and treatments. As part of its emergency response, FDA had to ramp up its regulatory processes to meet new, heightened demands. 

FDA splits its regulatory process into two stages: pre-market and post-market. In the pre-market phase, FDA reviews manufacturers’ applications to market products in the U.S. Once a drug is on the market, FDA continues its oversight of safety and effectiveness, which is termed as the post-market phase. 

FDA applies these regulatory functions across the entire agency. Different centers within FDA regulate specific products. For the Center for Devices and Radiological Health, for example, that would be medical devices.  

Before a medical device can be legally sold in the U.S., the manufacturer must have authorization from FDA. To be authorized, developers must present evidence that the device is reasonably safe and effective for its intended purpose. 

Elias Mallis, director of the Division of Industry and Consumer Education at FDA, told attendees at the agency’s Regulatory Education for Industry (REdI) Conference that the first thing manufacturers should do when starting this process is “gather the ingredients,” meaning collect resources and tools to present during a medical device submission.  

“There are four basic steps to bring a new medical device to market,” Diane Nell, consumer safety officer at FDA, said during the REdI Conference: 

• Classify your device and understand applicable regulatory controls.

• Select and prepare the correct premarket submission.

• Send your premarket submission to FDA.

• Comply with applicable regulatory controls including establishment registration and device listing.

One of the most popular ways to submit a medical device to FDA is through the 510(k) program, a premarket submission made to the agency to demonstrate that the device to be marketed is as safe and effective as a legally marketed device.  

FDA uses three levels of risk, categorized by three classes, to determine regulatory control. Routine inspections are mandated by law every two years for the first and second classes of device manufacturers, and premarket approvals (PMAs) are required for third-class medical devices.  

FDA’s Office of Regulatory Affairs (ORA) is responsible for inspections of firms and plants producing FDA-regulated products; investigations of consumer complaints, emergencies and criminal activity; enforcement of FDA regulations; sample collection and analysis; and review of imported products. 

With the onset of COVID-19, one way FDA streamlined its inspections and reviews was through remote regulatory assessments (RRAs). 

“RRAs were developed by the ORA as a means of assessment during the pandemic. All program areas ... have explored ways to leverage this tool to further the oversight activities in their program during this very challenging public health crisis,” a spokesperson from FDA’s ORA told GovernmentCIO Media & Research.  

While RRAs are not a substitute for in-person inspections, this new process has helped FDA’s staff engage with regulated establishments throughout the pandemic in ways that would not have been possible otherwise. This also allowed FDA and regulated establishments to maximize the use of available resources, the ORA spokesperson said.  

As more innovations come to market, FDA is looking to improve some of these regulatory functions by leveraging technology and improving data management. In FDA’s FY 2022 proposed budget, the agency requested an increase of $185 million to upgrade and modernize its physical and technological infrastructure, strengthen its workforce and improve scientific capability and regulatory structure.  

“By consolidating data systems and migrating to a reliable hybrid-cloud environment, the FDA can move closer to the speed of industry in streamlining workflows, reducing the cost of maintaining data and network security, and improving the timeliness of delivery of services,” Woodcock said in her published statement.