MedCon: CDRH director talks Center innovation, modernization, and new frameworks

COLUMBUS, OH – The US Food and Drug Administration’s (FDA) top medical device official touted her center’s recent accomplishments and provided an update on several ongoing initiatives at the 2026 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.

Michelle Tarver, director of the Center for Devices and Radiological Health (CDRH), who presented virtually at the meeting, said her center authorized 124 novel medical devices in 2025, the third highest total in the Center’s history. Many of the authorizations are in new clinical areas, such as a blood test that helps detect Alzheimer’s disease, said Tarver.

The advancements seen in the devices approved last year suggests “we’re making great strides in areas where there is unmet need in populations that have often gone without diagnostic or therapeutic devices,” Tarver told attendees.

“Together, these authorizations highlight both the pace and the impact of innovation that’s coming through our Center,” she said.

Digital innovations in CDRH

Tarver said that as innovation in medical devices continues, regulators need to similarly innovate to keep pace and “meet the moment,” which includes a greater focus on digital health.

“The Digital Health Center of Excellence plays a central role in coordinating policy, as well as regulatory science and expertise not only across CDRH, but across the agency and actually into the department,” she explained. “Its work spans software as a medical device, broad digital health technologies that could be used as outcome assessments, as well as strengthening the consistency of the application of policy across the center.”

Initiatives like the Regulatory Accelerator, on the other hand, are meant for stakeholders who may not have extensive experience in medical device regulation. The accelerator contains curated resources, a medical device software guidance navigator, as well as an opportunity for early orientation meetings with the agency to discuss new technologies.

“We encourage early orientation meetings where sponsors can come in and talk to us about their novel, complex technology,” Tarver said. “It’s like a show and tell. It gives us the opportunity to ask important questions prior to the actual regulatory submission coming in-house.”

Tarver also highlighted the agency’s cybersecurity guidance, which was released in February 2026 with changes to reflect the transition to the Quality System Management Regulation (RELATED: FDA reissues cybersecurity guidance to align with QMSR, Regulatory Focus 4 February 2026).

“Healthcare is increasingly becoming dependent on connected technology, and the FDA cybersecurity recommendations focus on ensuring that the device is safe and effective, which includes… adequate device cybersecurity throughout the total product lifecycle,” she said.

CDRH compliance transition

Tarver said that CDRH has made progress on its compliance transition that realigned compliance functions to the Center “to improve coordination, consistency, and timeliness in decision-making.”

Since the transition started in October 2024, CDRH has developed a more formalized and integrated inspection review process that includes domestic inspection reports. Tarver noted that CDRH works closely with the Office of Inspections and Investigations and the Office of Product Evaluation and Quality for “earlier engagement when inspections are trending towards more significant findings.”

“Together, all of these efforts are designed to ensure that we are taking a total product lifecycle approach, thinking holistically about the products that we regulate and bringing all the important expertise online throughout the entire review process, whether it's pre-market or post-market,” she said.

Early alert program

CDRH’s early alert recall pilot program was expanded in September 2025 to include all medical devices. Tarver said the program was initiated because “we heard very loud and clear from patient groups as well as provider organizations about the importance of timely communication about safety concerns.”

Tarver noted that FDA works much quicker under the early alert program, communicating with firms and publishing information as soon as new significant information is available.

“Shifting the communication process to earlier in the review process translates to focusing on the immediate corrective actions proposed by the firm and working with the recalling firm to address unmitigated risks,” she said.

Addressing supply chain challenges, third-party data integration

CDRH has also acknowledged that FDA does not currently have a mechanism for prioritizing medical devices that might encounter supply chain challenges.

“We’ve identified a need to better prioritize devices that are in shortage or at risk of shortage, where delays can directly impact patient care,” Tarver said. “We’re developing a more consistent risk-based approach to expedite import admissibility review for critical medical devices.”

Another issue is that CDRH currently does not have a standardized method for integrating third party data on medical devices. Tarver said CDRH is building a framework that would allow this, and they are currently examining whether data from the Accreditation Scheme for Conformity Assessment (ASCA), Medical Device Single Audit Program (MDSAP), and Voluntary Improvement Program (VIP) can be used to identify lower risk devices.

“This approach will support more efficient entry for compliant products, improve risk targeting, and strengthen overall supply chain oversight,” she said. “It is using all the information we have to make more informed decisions, and that is what we are planning to launch.”