Tarver asks for patience from industry as CDRH undergoes changes

WASHINGTON, DC – Despite the rapid changes happening at the US Food and Drug Administration (FDA), the Michelle Tarver, director of the Center for Devices and Radiological Health (CDRH), said the device center is still meeting its goals and asked stakeholders to be patient as it works to fulfill its mission.

Since President Donald Trump took office, FDA has lost thousands of its staffs to a combination of mass layoffs, buyout offers, and early retirements, with the most recent reduction-in-force (RIF) effort heavily affecting the agency’s communications, policy, and other non-review-related offices. Additionally, executive orders have limited the agency’s ability to issue new guidance and regulations without finding cost savings or trimming back other regulations. (RELATED: Experts: Trump executive orders create foundation for what’s to come, Regulatory Focus 24 January 2025; Trump's 10-for-1 order puts pressure on FDA to find regulations to nix, Regulatory Focus 7 February 2025)

Tarver made these remarks at the Medical Device Manufacturers Association (MDMA) Annual Meeting on 1 May. She noted that despite these changes, the agency is continuing to meet its expectations.

"I encourage you all to be patient with us,” Tarver told attendees. “There's a lot happening... but we are committed to meeting our goals, committed to advancing public health."

Sen. Amy Klobuchar (D-MN) also spoke at the meeting and raised concerns about the Trump administration’s actions involving FDA. She noted that despite FDA Commissioner Martin Makary’s recent comments that he does not plan to put the agency through another reorganization, or fire scientists or reviewers, it is still facing significant issues.

“Reportedly, experienced reviewers are leaving or recusing themselves from reviews while they search for new work ... which the FDA rules require,” said Klobuchar. “The result is that highly regulated devices approved by the FDA hit a 10-year low during the first quarter this year.

“It just shows that we're having a slowdown,” she added. “Only nine class III devices were approved during the first three months of 2025 despite the FDA last year receiving more applications than ever before.”

During a discussion with MDMA CEO Mark Leahey, Tarver noted that CDRH is on track to meet 15 of its 16 performance goals negotiated with industry under the Medical Device User Fee Amendments (MDUFA V). She also noted that the agency has continued to work on many of the programmatic aspects of the deal, such as global harmonization and the total product lifecycle advisory program (TAP).

Leahey noted that MDUFA V increased the capacity of the agency's presubmission program and that presubmisison requests have significantly increased over the past decade. Still, he added that some sponsors have complained that the responses from reviewers are often not vetted by their managers, and reviewers frequently ask for information that may not be necessary to authorize the product. He also said that instead of getting answers quickly through a phone call, the responses from the agency have become more structured and formalized.

"No side is right or wrong here, I'm just articulating a dynamic here where you have situation where there could be circumstances where you have a question and in the [presubmission] it's taking dozens of hours for FDA and the sponsor to prepare and get ready for, where a phone call could have resolved the issue and saved the FDA and the company resources," said Leahey.

Tarver said that every presubmission request needs to be evaluated based on the kind of question the sponsor is asking.

"I think the question is, is there a way to ensure that we are giving the input that folks need at the right time in the right way and answering the right questions that they have," she said.

Tarver used the analogy that if a person goes to a store to buy a pair of shoes and asks what the salesperson would recommend, they can expect the salesperson to ask questions such as what they want to buy the shoe for, what characteristics they are looking for in a shoe, and who they are buying the shoe for. She said sometimes the questions FDA gets are so broad that it's hard to answer the question without asking for more details.

"We've been encouraging companies, give us more detail, ask us what you really want us to answer, and we'll do the best we can to provide that input,” said Tarver. “We understand that in novel spaces where there is not a lot of guidance out there, there's not a standard, there's not a lot of things you can turn to and look to for information, those presub meeting are really helpful.”

Tarver said FDA wants to provide "fit-for-purpose feedback." She said that if the question warrants just a phone call, the agency will consider doing that instead of using a formal process. However, if it's something the sponsor wants to brainstorm, then the agency needs to evaluate how it approaches the questions and accommodates the sponsor’s needs.

Tarver asks for patience from industry as CDRH undergoes changes

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