Commentors ask FDA to withdraw 510(k) and thermal effects guidances

Industry stakeholders are asking the US Food and Drug Administration (FDA) to withdraw three draft guidances related to 510(k) submissions and a draft guidance on the thermal effects of medical devices that produce tissue heating or cooling. The commenters argued the documents are overly broad, conflict with other guidances, and are outside the agency’s regulatory scope.

Earlier this year, the Center for Devices and Radiological Health (CDRH) published its annual list of guidances it plans to prioritize over the next fiscal year. The list includes an A-List of guidances that it intends to publish, a B-List it will aim to publish depending on resources, and a list of guidances under construction.

Several industry stakeholders, including the medtech lobby group AdvaMed and device maker Abbott wrote to FDA asking it to remove some of the guidances from its list. A guidance of particular concern is the agency’s guidance on evaluating thermal effects of certain medical devices, which was published in draft form in 2024.

They both argued that the guidance is "overly broad" and will impede innovation. They also argued the guidance is too burdensome and goes contrary to Congress' mandate to the regulatory agency.

"We are concerned this broadly encompassing guidance that includes within its scope all premarket submissions, including (investigational device exemption (IDE)] Applications – without any delineation across the product lifecycle—will impede device discovery and development as it is inconsistent with the criteria for IDE applications and a least burdensome approach," said Abbott. "Further, the guidance has created much confusion because it conflicts with FDA established policies and FDA-recognized consensus standards."

The company also recommended withdrawing three 510(k) draft guidances published in 2023, including one on best practices for selecting a predicate device to support a 510(k) submission, evidentiary expectations for 510(k) implants, and using clinical data in 510(k) submissions. It again argued the draft guidances make recommendations that are not based on existing statutes and regulations and go against the agency’s longstanding regulatory practices.

“Use of guidance documents to establish new and/or changed requirements for an established submission pathway, 510(k), creates unpredictable regulatory expectations, increases FDA resources to review additional information, and stymies public health,” said Abbott.

AdvaMed agreed and also argued the 510(k) guidances are too burdensome.

“The policies and recommendations outlined in these draft guidance documents have raised significant concern across the medical technology community,” said the group. “Specifically, we believe they introduce considerable uncertainty and ineffectiveness into the regulatory process and contain recommendations that are not consistent with applicable statute or regulations.

“If finalized, these guidances could have far-reaching and unintended consequences—undermining regulatory predictability, discouraging innovation, and hampering patient care,” it added.

AdvaMed also said withdrawing the guidances would further President Donald Trump's executive order issued earlier this year to remove 10 rules, regulations, and guidances for each one issued. In furthering that goal, the group also asked FDA to conduct a retroactive review of older guidances to consider reintegrating them as part of its priorities.

"In this way, the Agency will ensure rescission or revision of guidance to reflect the latest thinking and clear regulatory expectations," the group added.

The industry stakeholders also listed guidances that they would like FDA to prioritize. For instance, AdvaMed and Abbott both supported FDA prioritizing a guidance on predetermined change control plans (PCCP).

“As noted in AdvaMed’s comments for this draft guidance, it is critical to ensure the recommendations in the guidance follow the least burdensome principles and reflect the broad authority granted to the FDA in the statute,” said AdvaMed. “As FDA works to finalize this guidance, we additionally recommend FDA review and update the ‘Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions’ guidance to ensure both documents are aligned.”

Both stakeholders also supported FDA's prioritization to revise its guidance on real-world evidence to support regulatory decisions. They said the revision would provide much-needed clarity. The continuous glucose meter (CGM) manufacturer Dexcom also supported revising the guidance.

“Dexcom CGM devices collect patient data during use,” said Dexcom. “This real-world data could provide insights into the performance and clinical outcomes associated with CGM use beyond traditional clinical trials.

“For this reason, revision and/or expansion of this guidance may help inform Dexcom how patient data collected during routine CGM use can be leveraged in the future for regulatory decision making,” the company added.

Abbott, AdvaMed, and Dexcom also commended FDA for prioritizing developing guidance on the lifecycle management of artificial intelligence-enabled (AI-enabled) devices.

"Dexcom believes that artificial intelligence (AI) and/or machine learning (ML) technology is advancing the next generation of medical devices," said Dexcom. "Issuance of this guidance will offer clarity on the premarket documentation expectations for AI/ML enabled devices and strengthen FDA’s support for development in this space."

AdvaMed similarly said that finalizing the guidance would offer clarity and provide sponsors of AI-enabled devices with more consistency, but asked the agency to ensure it can be applied to different situations.

"The draft guidance applies a one-size-fits-all approach to submission content and postmarket oversight for all AI-enabled devices," said the group. "AI is not a monolithic technology, and different types of AI carry different risks and performance considerations.

"As FDA works to finalize the guidance, we strongly encourage revisions that tailor the recommendations to the unique considerations for the respective types of AI, as discussed in AdvaMed’s comments on the draft guidance," it added. "Further, AI continues to be an area of high growth and rapid change. As such, we recommend this guidance should be prioritized to the A list."

The stakeholders supported FDA's prioritizing of guidances that address patient preference information (PPI), validation of diagnostic tests for public health emergencies, human factors information, real-world evidence, quality management system information, and policy for device software functions.

Stakeholder comments

CDRH FY2026 guidance priorities

Commentors ask FDA to withdraw 510(k) and thermal effects guidances

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