PFAS Reporting Extension: Healthcare Companies Get a Pause, Not a Pass

There has been a delay to the PFAS reporting rule under TSCA Section 8(a)(7). For most manufacturers and importers, data submission now begins on April 13, 2026, with a deadline of October 13, 2026. Manufacturers in the healthcare industry may be breathing a sigh of relief due to the delay or because they believe FDA oversight puts them outside the scope of these requirements.

And it’s true that TSCA doesn’t cover FDA-regulated items, but that’s just part of the bigger picture. Most manufacturers work with a mix of products and components, such as treated fabrics, tubing, filters, and other accessories, that could still be in scope of TSCA.

Ultimately, many healthcare manufacturers will be impacted by PFAS requirements. The industry demands are massive, requiring significant investments in time and resources to get it right. Companies that become complacent could face significant fines and damage to their brand down the line.

Further Delays Unlikely

This is not the first delay to this reporting deadline, but those hoping for further delays are likely to be disappointed. The delays were caused by technical issues with the EPA’s Central Data Exchange (CDX) system, which was already struggling to manage TSCA Section 8(a) Chemical Data Reporting (CDR) program submissions in 2024.

However, the agency is on track to put these issues behind them. In April 2025, Congress allocated $17 million to modernize the system and address ongoing security and functionality concerns. Assuming that funding will stay in place along with a reasonable timeline, companies can expect that the new deadline is here to stay.

The Path to Compliance 

Even if a company’s medical devices are out of the scope of TSCA because they are FDA-regulated, manufacturers still need to pay attention to compliance. This is because a company’s entire portfolio usually encompasses more than just medical devices. Peripherals, accessories, treated fabrics, fluoropolymer tubing, membrane filters — essentially anything that doesn’t require FDA oversight — are likely in the scope of TSCA requirements if imported into the U.S. between 2011 and 2022. Companies may also have imported materials containing PFAS for other non-FDA purposes that could require reporting. 

The use of PFAS in manufacturing is getting more complex by the day as more regulations are implemented globally and supply chains increasingly discontinue the manufacture of PFAS and materials that contain it. To avoid disruptions and impacts to the bottom line, the only reasonable response to this delay is to keep moving forward with compliance. Here’s how manufacturers should make the most of this extension:

1. Uncover Hidden PFAS in the Supply Chain

Examine processes and products to identify PFAS. This should include coatings, membranes, films, resins, and fluorinated packaging.

2. Work With Suppliers

Regulatory requirements are far from the only concern for manufacturers. Parts obsolescence is a huge risk to business continuity. If the parts need to have PFAS in them, the companies that produce them may phase them out — and with big names like 3M stopping PFAS production as soon as the end of this year, it’s only a matter of time before those parts become unavailable. Companies must be sure to communicate with suppliers to determine timelines for product reformulations and phase-outs.

3. Start the Product Redesign Process

The sooner companies start, the better. Even FDA-compliant devices may need to be redesigned if the necessary parts are unavailable, and the process for redesigning, requalifying, and recertifying for the market can take two years or more.

4. Watch State Laws

In addition to federal requirements and parts obsolescence, state-level requirements will also pose significant challenges for manufacturers. Take this time to ensure alignment with the requirements for every market you sell in, including California, Maine, Minnesota, and dozens of others that are moving ahead with their own PFAS reporting and/or restriction rules.

Deregulation & the Future of PFAS Reporting

With all the recent talk of deregulation, it’s no wonder some people expect changes to these rules. That’s why it’s essential to look beyond the headlines and gain a comprehensive understanding of the political and regulatory landscape.

The TSCA Section 8(a)(7) reporting requirement was included in the 2020 National Defense Authorization Act, which, was notably signed by President Trump during his first term. More recently, the administration has indicated that chemical compliance will continue to be required — chemical regulations were not included on EPA Administrator Lee Zeldin’s deregulation to-do list. This is likely because chemical regulations tend to be more bipartisan. Manufacturers that were expecting a four-year reprieve from chemical compliance may find themselves in a precarious position.

And, as mentioned, even with a delay from the EPA at the U.S. federal level, manufacturers still face a patchwork quilt of regulations at the state level and in other countries. Healthcare equipment and medical devices are not always exempt from these regulations — and even when exempt from the restrictions, they are often in scope of reporting obligations (for example, health-related items were not excluded from reporting requirements in Canada). Suddenly, the nine-month reprieve offers manufacturers little relief from this unprecedented regulatory maelstrom.

Final Word: The Clock Is Ticking

Companies should view this extension as an opportunity to collect and report on the EPA-required “look back” PFAS data more decisively. It’s also an opportunity to find PFAS in current products and phase them out, as other regulations, along with risks tied to obsolescence, litigation, insurability, and customer demand, continue to drive PFAS programs.