Industry groups are calling for the withdrawal of multiple draft guidances related to 510(k) submissions and the evaluation of medical devices that generate tissue heating or cooling. Commenters argue that the documents are overly broad, inconsistent with longstanding regulatory practices, and risk imposing burdens that could slow medtech innovation.
The feedback comes as the Center for Devices and Radiological Health (CDRH) finalizes its FY 2026 guidance priorities, which categorize planned documents into an A-List, B-List, and guidance projects already underway.
Concerns Over Draft Guidance on Thermal Effects
A major point of contention is FDA’s 2024 draft guidance on thermal effects for devices that heat or cool tissues. Stakeholders including Abbott and AdvaMed stated that the scope of the document is excessively broad, applying to all premarket submissions—including IDE applications—without distinguishing between device types or stages of development.
Abbott noted that the recommendations contradict established FDA policies and consensus standards, potentially slowing early research and making IDE approval more burdensome. Both organizations argue the draft conflicts with Congress’s instruction that the agency follow a least-burdensome approach to device regulation.
Pushback on Three Draft 510(k) Guidances
Stakeholders also asked FDA to rescind three draft guidances issued in 2023:
- Best practices for selecting a predicate device
- Evidentiary expectations for 510(k) implants
- Use of clinical data in 510(k) submissions
Industry commenters assert that the recommendations redefine core elements of the 510(k) pathway in ways not supported by statute. They warn that the proposals would make regulatory expectations less predictable, increase review burdens, and ultimately slow patient access to innovation.
AdvaMed emphasized that finalizing these guidances “could have far-reaching and unintended consequences,” including erosion of regulatory predictability and added uncertainty for manufacturers.
Alignment With Broader Deregulatory Efforts
Some commenters referenced the federal directive requiring the removal of older or redundant regulations for every new rule issued. They argue that withdrawing these draft guidances aligns with ongoing efforts to streamline regulatory expectations and eliminate outdated policy documents.
Stakeholders also encouraged FDA to conduct a retrospective review of longstanding guidances to determine which should be rescinded, updated, or harmonized.
Which Guidances Should Be Prioritized Instead?
While recommending withdrawal of certain documents, industry groups also identified guidances they strongly support, including:
• Predetermined Change Control Plans (PCCPs) – Particularly for AI-enabled device software, where clarity is essential for lifecycle management.
• Revised real-world evidence guidance – Needed to help companies understand how patient-generated data can support regulatory decisions.
• AI/ML-enabled device lifecycle management – Consistently cited as a high priority given the rapid evolution of intelligent device technologies.
Companies such as Dexcom highlighted how real-world CGM data could strengthen regulatory submissions if FDA provides clearer pathways for its use.
Stakeholders further endorsed prioritizing guidances on patient preference information, human factors considerations, diagnostic test validation, QMS expectations, and device software functions.
Looking Ahead
As FDA finalizes its FY 2026 guidance agenda, manufacturers and trade groups are emphasizing the importance of clarity, consistency, and alignment with statutory authority. The strong stakeholder response underscores the need for guidance that supports innovation while maintaining safety—and avoids introducing burdens that could hinder early-stage development.
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Reference:
Al-Faruque, F. (2025, December 8). Commentors ask FDA to withdraw 510(k) and thermal effects guidances. Regulatory Focus, RAPS.
U.S. Food and Drug Administration. (2025). CDRH Guidances for FY 2026.
AdvaMed, Abbott, and Dexcom public comments submitted to Regulations.gov (2025).
