COLUMBUS, OH – The US Food and Drug Administration’s (FDA) device center is putting the COVID-19 pandemic in the “rearview mirror” while seeking to maintain the flexibility and proactive engagement with industry that the center employed during the public health emergency.
“There’s a lot of things we had to do on the fly in COVID that really informed us about what we need to look like as an organization in the future,” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH) told attendees at the 2023 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative and FDA.
“Science and technology are changing faster and faster. We have to be nimble and be able to pivot on a dime,” he said.
EUA transition
In March 2023, CDRH issued two final guidance documents aimed at transitioning medical devices that were issued emergency use authorizations (EUAs) during COVID-19, or which fall into the center’s enforcement discretion. Shuren advised members of industry with devices that fall into these categories to read through the guidance documents. “It tells you what to do and when you need to do it,” he said.
He also advised companies to begin planning today and to understand the gap between the evidence that was needed for an EUA and what will be required to obtain full marketing authorization. (RELATED: FDA’s top 10 tips to transition your COVID-19 products, Regulatory Focus 22 November 2022)
Don’t wait for the deadline to send in a premarket submission, Shuren said. “Even though if you get it in on time you’ll stay on the market, your competitor may be in the door beforehand and that means they will get out the door likely beforehand with full marketing authorization and get a competitive advantage,” he said.
MDUFA V
CDRH is also focused on implementation of the Medical Device User Fee Amendments (MDUFA V), which was reauthorized in September 2022. Shuren noted that the program has evolved over the years to move beyond the focus on review capacity to include a several policy initiatives, including digital health transformation and work on real-world evidence, quality management, international harmonization efforts, patient engagement, the Total Produce Life Cycle Advisory Program (TAP) pilot, and others.
The TAP pilot, which launched in January 2023 and currently includes four devices, focuses on providing early engagement between the agency, device sponsors, and external stakeholders with the aim of getting products into the marketplace. (RELATED: FDA opens TAP, Regulatory Focus 3 January 2023)
Shuren explained that the program looks beyond FDA marketing authorization, to issues like coding, coverage, and adoption in the marketplace. As part of the pilot, CDRH has created new positions for so-called TAP advisors. These advisors act as a “bridge” between device sponsors and the FDA review team, looking to identify and address issues in as close to real time as possible. Shuren noted that sponsors still have direct access to the review team, but that TAP participants now have another person providing support.
Workforce
Another focus in the coming year is expanding CDRH’s workforce. The center has hiring targets under MDUFA V, as well as other open positions within the center. Shuren said that FDA’s workforce has changed over time and that fewer people are looking to spend their entire careers with the agency, but rather are using it as a “steppingstone” to other jobs. That makes it essential to train staff quickly, he said.
Shuren said CDRH is making progress on hiring and has expanded its recruitment reach, including an upcoming virtual career fair. Along with recruitment efforts, CDRH is building out more professional development opportunities for existing staff.
“It’s a combination of what we’re doing on the recruitment side, on retention, and how we make the organization increasingly a more attractive place to come,” he said.
“There’s a lot of things we had to do on the fly in COVID that really informed us about what we need to look like as an organization in the future,” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH) told attendees at the 2023 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative and FDA.
“Science and technology are changing faster and faster. We have to be nimble and be able to pivot on a dime,” he said.
EUA transition
In March 2023, CDRH issued two final guidance documents aimed at transitioning medical devices that were issued emergency use authorizations (EUAs) during COVID-19, or which fall into the center’s enforcement discretion. Shuren advised members of industry with devices that fall into these categories to read through the guidance documents. “It tells you what to do and when you need to do it,” he said.
He also advised companies to begin planning today and to understand the gap between the evidence that was needed for an EUA and what will be required to obtain full marketing authorization. (RELATED: FDA’s top 10 tips to transition your COVID-19 products, Regulatory Focus 22 November 2022)
Don’t wait for the deadline to send in a premarket submission, Shuren said. “Even though if you get it in on time you’ll stay on the market, your competitor may be in the door beforehand and that means they will get out the door likely beforehand with full marketing authorization and get a competitive advantage,” he said.
MDUFA V
CDRH is also focused on implementation of the Medical Device User Fee Amendments (MDUFA V), which was reauthorized in September 2022. Shuren noted that the program has evolved over the years to move beyond the focus on review capacity to include a several policy initiatives, including digital health transformation and work on real-world evidence, quality management, international harmonization efforts, patient engagement, the Total Produce Life Cycle Advisory Program (TAP) pilot, and others.
The TAP pilot, which launched in January 2023 and currently includes four devices, focuses on providing early engagement between the agency, device sponsors, and external stakeholders with the aim of getting products into the marketplace. (RELATED: FDA opens TAP, Regulatory Focus 3 January 2023)
Shuren explained that the program looks beyond FDA marketing authorization, to issues like coding, coverage, and adoption in the marketplace. As part of the pilot, CDRH has created new positions for so-called TAP advisors. These advisors act as a “bridge” between device sponsors and the FDA review team, looking to identify and address issues in as close to real time as possible. Shuren noted that sponsors still have direct access to the review team, but that TAP participants now have another person providing support.
Workforce
Another focus in the coming year is expanding CDRH’s workforce. The center has hiring targets under MDUFA V, as well as other open positions within the center. Shuren said that FDA’s workforce has changed over time and that fewer people are looking to spend their entire careers with the agency, but rather are using it as a “steppingstone” to other jobs. That makes it essential to train staff quickly, he said.
Shuren said CDRH is making progress on hiring and has expanded its recruitment reach, including an upcoming virtual career fair. Along with recruitment efforts, CDRH is building out more professional development opportunities for existing staff.
“It’s a combination of what we’re doing on the recruitment side, on retention, and how we make the organization increasingly a more attractive place to come,” he said.
Source: News