FDA’s Risk-Based Approach to PTFE Material Substitution: What OEMs Should Know
PTFE Supply Risk Is Now a Regulatory Reality
Fluoropolymers such as PTFE have long been used in medical devices. In recent years, FDA has acknowledged increasing supply-chain stress as several fluoropolymer manufacturers exit the medical device market. This shift has prompted device manufacturers to evaluate material substitutions to maintain product continuity and supply resilience.
How FDA Evaluates Material Changes Under the 510(k) Framework
FDA’s 510(k) “Deciding When to Submit” (Mods) Guidance emphasizes a risk-based approach when assessing changes to legally marketed devices. For material changes, manufacturers are encouraged to evaluate:
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Whether the material change introduces new biocompatibility risks
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Whether device performance specifications are affected
When risk analysis (for example, ISO 14971) demonstrates negligible risk and device performance remains unchanged, FDA notes that a new 510(k) submission may not be required, and documentation via a Letter-to-File may be appropriate.
Any regulatory determination remains the responsibility of the device manufacturer, based on its own risk assessment and regulatory strategy.
What “Negligible Risk” Means in Practice
FDA does not expect manufacturers to focus on hypothetical risks unsupported by scientific evidence. Instead, material changes should be evaluated based on realistic exposure, material chemistry, and device function within the intended use of the device.
Designing Alternatives With Regulatory Continuity in Mind
As OEMs assess PTFE alternatives, design intent plays an important role. Materials developed to match PTFE’s functional performance—while maintaining processing compatibility and stable supply—are more likely to support streamlined regulatory pathways and continuity across product lifecycles.
A Practical Path Forward
At Dynaflex, alternative liner technologies are developed with these principles in mind, focusing on functional equivalence, process compatibility, and regulatory awareness. Ultimately, each OEM must perform its own risk assessment and regulatory evaluation, but FDA’s guidance provides a clear framework for navigating material transitions responsibly.
Reference (for regulatory context):
FDA CDRH Webinar, “Material Substitutions in Devices Subject to Premarket Notification (510(k)) Using PTFE,” December 10, 2025.
