House Health Subcommittee Grills FDA Officials Over Medical Device Failures

Representatives peppered the FDA commissioners with questions during a Wednesday hearing before the House Energy and Commerce Committee’s Health Subcommittee on the Food and Drug Administration’s (FDA) regulation of drugs, biologics, and medical devices.

The lawmakers said they aim to investigate why FDA rules deny doctors and patients access to tests that require lengthy premarket approval periods, how the FDA is reviewing devices that use artificial intelligence and machine learning, and other topics. They also asked about third-party certification and other topics.

Several committee members urged FDA commissioners to improve communication with applicants.

Digital Products Too late to innovate

Health subcommittee Chairman Brett Guthrie (R-Ky.), in opening remarks at a congressional hearing on Wednesday, said some missteps on the bipartisan-backed path have caused “uncertainty among progressives.”

“CMS’s repeated attacks on the expedited approval process, questioning the FDA’s fairness to academics and payers and arguing that these approvals are unproven or inferior to traditional review methods, undermine public trust,” he said.

“The FDA can’t go back,” but in 2023, “all three centers, despite record funding, have missed key performance process and employment targets,” said Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.).

Officials also reported that FDA employees are “more isolated than ever and harder to work together.”

“Everyone wants the FDA to succeed,” but the committee wants to know what challenges the agency faces, why, and how Congress can help, she added.

To attract more innovation, Dr. Jeff Shuren, director of the Center for Devices and Radiological Health, said:FDA Launches Breakthrough Device ProgramWe currently designate 100 innovative medical devices per year.

The program aims to identify and provide access to devices that can improve treatment or diagnosis to patients and medical professionals. In its final guidance released in September, the FDA said it may consider improved access to devices when determining whether a device meets the initial breakthrough criteria.

However, with numerous obstacles to go from concept to commercialization, most devices never reach patients.

“It really deserves to be called the Valley of Death,” he said.

It’s a pilot program in which FDA advisers are working proactively and strategically with innovators to identify challenges, such as payer reimbursement, and Shuren said the feedback has been positive.

He told the committee that one company had shaved a year off its development time by participating.

Digital Products The Need for Third-Party AI Certification

According to Shuren, the FDA has also approved 900 AI/ML medical devices.

But to drive innovation, a third-party certification model needs to be put in place, and that requires support from Congress, he said.

Shuren, who has been CDRH director for 15 years, said the agency made the change to attract innovation because new technology wasn’t initially available to the U.S.

But by 2023, he said, there will be a “five-fold increase” in new technologies, with 124 approvals (excluding COVID-19-related devices).

But “existing gaps exist, for example, with respect to the agency’s ability to effectively oversee the drug and medical device supply chains,” the FDA witnesses said jointly.Written testimony.

“Similarly, existing regulatory pathways do not provide sufficient flexibility for medical device manufacturers to adopt best practices for the development, deployment, and ongoing maintenance of AI/ML-enabled medical devices,” they said.

Shuren said the FDA needs access to large data sets to jumpstart smaller innovators in the field and is considering federated models and learning from the Department of Veterans Affairs.

To keep medical device cybersecurity in line with security-by-design requirements, the FDA requires companies to design medical devices “in a way that allows for patching,” Shuren said.

Digital Products Balancing safety and innovation in LDT

Several committee members asked about the agency’s approach to regulating laboratory-developed tests. The final rule, released May 6, confirms the FDA’s position that LDTs ​​are in vitro diagnostic products and are regulated as medical devices under the Federal Food, Drug, and Cosmetic Act.

Guthrie questioned why hospitals and patients would be barred from obtaining testing under “burdensome requirements” under the new system proposed by CDRH, and Rogers said the ruling is an “expansion of the executive branch’s power” that will affect how health care providers diagnose and treat patients.statement.

“While the final rule is a slight improvement over the proposed rule, it will still increase costs and reduce access to diagnostic and medical tests that provide important information for physicians to effectively treat patients,” she said.

Rep. Diana DeGette, D-Colorado, noted that LDT currently uses complex software that “informs critical life-threatening decisions.”

While the final LDT rule maintains exceptions as previous enforcement discretion elements are diluted over four years, it lists important factors that can cause diagnostics to get stuck in FDA review. Guthrie cited 664 clinical holds from 2017 to 2021 and the FDA’s policy of providing written responses to applicants without any dialogue with them.

“That’s unacceptable,” Guthrie said.

Notably, lab tests or diagnostic tests modified with new technologies, such as the addition of AI or ML, will require premarket review and compliance with FDA quality system requirements under the final rule.

Rep. Troy Balderson, R-Ohio, asked about expediting approval of AI/ML products that the FDA says it can’t handle, and how the FDA can change that.

Shuren said the FDA has approved 900 AIs/MNLs but shares those concerns.

“These particular features are kind of low-level diagnostic features,” he explained.

“As we move to generative AI, [regulatory] The framework is not fit for purpose and is really designed around the hardware.”

Shuren said the AI ​​needs more robust post-market modeling so the FDA can monitor what’s happening to reduce the risk of bias.

He also said the amount of stuff being created using AI/ML will “exponentially grow,” but that officials will never have the resources to look at it all.

“It’s unrealistic to expect that,” he said, noting that a third-party certification model is needed to regulate the technology, “but that would require support from Congress.”

Dr. Miller-Meeks accused CDRH of stifling innovation with its 500-plus page rule and questioned why real-world evidence is sometimes used and sometimes ignored.

In a previous response, Shuren said there are “problematic” tests out there that don’t produce good results for patients, potentially preventing them from receiving the right treatment.

“Today, if you have cancer, whether or not you get the right treatment depends on which lab you go to, rather than on the biology of your tumor,” he said. “That’s just not acceptable.”

The FDA has the expertise to evaluate the models underlying algorithms but doesn’t have the infrastructure, said Dr. Patricia Calvizio, director of the FDA’s Center for Drug Evaluation and Research, noting the high costs of evaluating models.

“They’re finding a way to do it for now,” but the FDA is looking at ways to scale it up in the future.

Digital Products FDA asks about CHAI

Miller-Meeks also asked whether the FDA would outsource certification.Healthcare AI Alliance“It’s not a diverse group,” he said, pointing out that Google and Microsoft were founding members and that the Mayo Clinic, which has more than 200 AI deployments, employs some of its leaders.

“There’s no question about this,” she said, showing “clear signs of attempted regulatory capture.”

Shuren responded that CDRH engages with CHAI as a federal liaison, as it does with other AI industry coalitions, but does not engage with the organization to review applications.

“We told CHAI, too, that we need more representation in the medtech space,” he said, adding that his office might take CHAI’s work into consideration, but “they don’t work for us, and we don’t work for them.”

Andrea Fox is a senior editor at Healthcare IT News.
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