FDA Reaffirms Safe Use of Fluoropolymers (PTFE) for Medical Devices. What It Means for Inks & Coatings

Over the last few years, I’ve been helping companies navigate the use of PTFE (a fluoropolymer in the PFAS family) in inks and coatings. The FDA just released new guidance confirming that fluoropolymers used in medical devices are considered safe and essential and there is no reason to restrict their use. Medical device applications include catheters, guidewires, vascular grafts, drug delivery tubing, and nonstick surgical coatings.

Here are some of the key takeaways from the FDA statement:

Not All PFAS Are Equal 

The FDA emphasized that large-molecule fluoropolymers like PTFE are fundamentally different from their smaller PFAS counterparts linked to environmental and health concerns.

Safety Confirmation 

Based on an independent safety review by ECRI[1] and FDA, the agency found no evidence that PTFE causes patient harm in medical devices.

Certain PFAS are Critical for Technical Applications 

Fluoropolymers deliver unique, irreplaceable properties including lubrication, electrical insulation, and biostability vital in medical devices. No alternative materials currently offer the same performance.

 What This Means for Inks & Coatings

• Validation of PTFE’s Safety & Utility: This FDA stance reinforces PTFE’s role in demanding formulations where properties such as durability, slip, or chemical resistance are essential.

  
  

• Communication Around Fluoropolymer Use: Messaging and compliance should reflect that PTFE-based materials (high molecular weight fluoropolymers) differ from the small PFAS under regulatory scrutiny.

  
  

• Fluoropolymer Purity: While high molecular weight fluoropolymers like PTFE are considered non-migratory and inert, formulators should enquire with fluoropolymer vendors and submit for third-party testing of residual PFAS monomers which may pose regulatory and toxicological risks.  For example, formulators may consider LC-MS/MS testing of final coatings to confirm PFOA levels are below 25 ppb.

The FDA’s decision provides much needed clarity around PTFE’s safety in performance applications. If you’re working with specialty inks, coatings, or smart materials using fluoropolymers it is important to understand product requirements and educate stakeholders. If you’d like help with product development or compliance messaging around PTFE, Summit Analytical can help.

[1] The ECRI is a nonprofit that provides independent evaluations and safety guidance on medical technologies