Convergence: CDRH on track to meet its FY 2023 MDUFA V performance goals, says Tarver

LONG BEACH, CA – According to Michelle Tarver, acting director of the Center for Devices and Radiological Health (CDRH), the center has either met or is on track to meet its FY 2023 performance goals for submissions under the Medical Device User Fee Amendments (MDUFA V). She also highlighted other CDRH initiatives intended to promote the development of medical devices, improve product safety, and encourage quality by manufacturers.

When the MDUFA V deal was negotiated between the US Food and Drug Administration (FDA) and industry, several goals were laid out over the five-year program cycle. Tarver spoke remotely about the center’s progress on some of these goals at RAPS Convergence 2024. While it’s too early to discuss performance goals for the FY 2024 submission cohort, Tarver noted that the agency was optimistic about meeting its goals for the most recent fiscal year.

“We are on track or have met our goals for FY 2023, and this is with the highest volume of premarket submissions that we've seen in at least a decade,” said Tarver. “Even in the presence of this increased workload, we are meeting the goals. In fact, we have exceeded by 20% our pre-submission goals.”

Tarver presented the following table that includes data up to the end of June on CDRH’s progress under MDUFA V:

MDUFA V Performance Review Data
Submission Type	FY2023 Performance
Original PMA's, PDPs, Panel-Track PMA Supplements, and Premarket Reports
Substantive Interaction	Goal met
Decision with No Advisory Committee Input	Goal on track
Decision with Advisory Committee Input	Goal on track
180-Day PMA Supplements
Substantive Interaction	Goal met
Decision	Goal on track
Real-Time PMA Supplements
Decision	Goal met
De Novo Classification Requests
Decision	Goal met
510(k) Premarket Notifications
Substantive Interaction	Goal on track
Decision	Goal on track
Pre-Submissions
Provide Written Feedback	Goal met

Besides the MDUFA V performance goals, Tarver also highlighted some accomplishments under the program including issuing and updating key guidances such as those for pre-submissions, Deficiency Letters, and predetermined change control plans (PCCP). She also noted the agency has launched and expanded its Total Product Lifecycle Advisory Program (TAP), and filled all 141 FY23 hires and all 42 FY24 hires as required under MDUFA V.

Tarver also updated the audience on CDRH's Breakthrough Devices Program, noting that the center has designated 1,008 devices as breakthrough devices to date.

"It takes time for the evidence to accumulate and for the submissions to reach us, but we have authorized 119 of those devices with a healthy mix of PMAs and 510(k)s,” Tarver said, including 37 premarket approvals (PMAs), 49 510(k)s, and 33 de novo classification requests to products with breakthrough designation.

Tarver provided details on the Safer Technologies Program (STeP) for devices and device-led combination products that are intended to significantly improve safety compared to currently marketed products. She noted that while companies have asked for more than a hundred products to be included in the program, so far, 44 products have been added to the program, and two of them have been granted marketing authorization.

She also touched on CDRH’s work to finalize the Quality Management System Regulation (QMSR) rule, which amended FDA regulations by incorporating the ISO 13485 standard and is intended to ensure more predictable, safe, and effective medical device manufacturing.

“This QMSR lessens the burden on device manufacturers and importers by modernizing regulation expectations and harmonizing domestic and international requirements,” said Tarver. “While this is a great step forward for harmonizing and simplicity, compliance with QMSR is just not enough to truly drive quality across an organization.”

She said basing a product design and quality on regulations alone can lead manufacturers to have a more reactive mindset and doesn’t encourage predictive practices to continuously improve their products. She added that FDA is working with other stakeholders and coming up with ways that companies can be more proactive about the quality of their products.

In particular, Tarver highlighted CDRH’s Case for Quality (CfQ) Voluntary Improvement Program (VIP), which is overseen by the Medical Device Innovation Consortium (MDIC) and uses a third-party appraiser. She noted that while the number of Class I recalls for medical devices has shot up from 59 in 2022 to 100 in 2023, devices in VIP have seen a significant dip in the number of the same kind of recalls from 6 to 2.

“As of April, of this past year, over 100 facilities have enrolled in the Volunteer Improvement program pilot and are moving now to a full-fledged program,” said Tarver. “What we have seen in those sites that have implemented and participated in this program is that there has been a culture change, continuous improvements, savings, improved patient access, and improved patient safety.”

Convergence: CDRH on track to meet its FY 2023 MDUFA V performance goals, says Tarver

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