House Health subcommittee criticizes FDA leaders for medical device missteps

During the House Energy and Commerce Health Subcommittee hearing on the U.S. Food and Drug Administration’s (FDA) regulation of drugs, biological products and medical devices on Wednesday, representatives fired questions at FDA directors.

The lawmakers said they wanted to examine how FDA rules prohibit doctors and patients from accessing tests that would require lengthy pre-market approvals, and how the agency is approaching a review of artificial intelligence and machine learning devices. They also asked about third-party certification and other topics.

Several committee members also urged FDA directors to improve communication with applicants.

Too slow for innovation

Health Subcommittee Chairman Brett Guthrie, R-Kentucky, said during opening remarks at the congressional hearing Wednesday that several missteps have created “uncertainty among innovators” along the bipartisan path.

“The repeated attacks on CMS’s accelerated approval pathway, which questions the FDA’s equity to both academics and payers, and insists that these approvals are unproven or inferior to traditional review pathways, erodes public confidence,” he said.

“The FDA cannot go backwards,” but by 2023 “all three centers were failing to meet critical performance process and recruitment goals, despite record highs in funding,” said Energy and Commerce Chairman Cathy McMorris Rodgers, R-Washington.

Stakeholders also reported that FDA staff are “more distant and more difficult to work with than ever before.”

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

To attract more innovation, Dr. Jeff Shuren, director of the Center for Devices and Radiological Health FDA launched its Breakthrough Devices Program which now identifies 100 innovative medical devices per year.

The program aims to identify patients and healthcare professionals and provide access to devices that can improve treatment or diagnoses. The latest guidance, released in September, says the FDA may consider increased access to a device while determining whether it meets the first breakthrough standard.

However, most devices do not reach patients as there are a number of obstacles from concept to commercialization.

“It is aptly called the Valley of Death,” he said.

A pilot program where FDA advisors proactively and strategically work with innovators and identify their challenges, such as payer reimbursement, and Shuren said the feedback has been positive.

One company said they had saved a year of development by participating, he told the committee.

Need for third party AI certification

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

However, a third-party certification model must be in place to promote innovation, and for that the agency needs help from Congress, he said.

Shuren, director of CDRH for 15 years, said no new technologies were initially offered to the United States, and the agency had made changes to attract innovation.

But by 2023 there was a “fivefold increase” in new technologies with 124 approvals (excluding COVID-19 devices), he said.

“However, there are existing gaps regarding the agency’s ability to effectively monitor drug and medical device supply chains, for example,” the FDA witnesses said in their joint statement. written testimony.

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

Shuren said that to activate small innovators in the space, the FDA needs access to large data sets and looks at federated models and learns from the Veterans Affairs agency.

To control medical device cybersecurity with secure-by-design requirements.

The FDA requires companies to design medical devices “in a way that allows them to be patched,” Shuren said.

Balancing LDT safety with innovation

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

Guthrie questioned banning hospital and patient access to testing under “onerous requirements” under the new regime proposed by CDRH, and Rodgers described the ruling as “executive overreach” that would affect how healthcare providers diagnose and care for patients in an earlier period. rack.

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

Congresswoman Diana DeGette, D-Colorado, noted that LDTs ​​now use complex software that “makes decisions that are extremely life-threatening.”

While the final LDT rule maintains an exception as previous elements of enforcement discretion diminish over four years, it lists important factors that could cause a diagnosis to stall in FDA review. Guthrie cited 664 clinical holds from 2017 to 2021 and the FDA’s policy of providing only written responses to applicants – without dialogue with applicants.

“It’s not acceptable,” Guthrie said.

Note that laboratory and diagnostic tests modified with new technology – such as the addition of AI or ML – would trigger the need for pre-market review and compliance with FDA quality system requirements under the final rule.

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

Shuren said the FDA has authorized 900 AI/MNL, but shares that concern.

“These specific functionalities are a kind of lower-level diagnostics,” he explained.

“As we move to generative AI, the current (regulatory) framework doesn’t fit the purpose, it’s really designed around hardware.”

Shured said AI requires more of a post-market model so the FDA can monitor what’s happening to reduce the risk of bias.

He also said that the numbers produced using AI/ML will “skyrocket” and that the agency would never have the resources to review everything.

“It’s unrealistic to expect that,” and regulating the technology requires a third-party certification model, he said. “But that will require help from Congress.”

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

In an earlier response, Shuren said there are “problematic” tests that don’t perform well for patients, and they may not get the right treatment.

“If you’re a cancer patient today, whether or not you get the right treatment depends more on the lab you go to than on your tumor biology,” he said. “Not acceptable.”

To evaluate models that support algorithms, the FDA has the expertise, but not the expertise

Infrastructure, says Dr. Patricia Carvizzio, director of the FDA’s Center for Drug Evaluation and Research, noting the high cost of revising the models.

“We’re finding ways in the meantime,” but the FDA is exploring how to scale up for the future.

FDA asked about CHAI

Miller-Meeks also asked whether the FDA would outsource certification to the Coalition of Healthcare AI, saying it was not a diverse body. She noted that Google and Microsoft are founding members, while Mayo Clinic, which she said has more than 200 AI implementations, employs some of its leaders.

“It does not pass the odor test,” she said, and shows “clear signs of attempted regulatory action.”

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

“We also told CHAI that they need more representation in the medical sector.” While his office might consider CHAI’s work, he said, “They don’t work for us, and we don’t work for them.”

Andrea Fox is editor-in-chief of Healthcare IT News.

Healthcare IT News is a HIMSS Media publication.