Innovative Health Clearance Shows How FDA Regulates Reprocessed Single-Use Devices

Innovative Health, a Scottsdale, Arizona company that reprocesses cardiology and electrophysiology devices, said on January 13 that it had received its 50th clearance from the Food and Drug Administration. The company's announcement said the newest clearance lets it reprocess the Agilis NxT Steerable Introducer, originally manufactured by Abbott, "for two additional uses in the lab." FDA's 510(k) database entry lists the device as a reprocessed catheter introducer, class II, received on February 3, 2025 and found substantially equivalent on January 7, 2026.

The company's chief executive, Rick Ferreira, said "Fifty clearances in 10 years is something to be proud of." It also shows how FDA handles a device that the original maker labeled for one use, after someone else cleans it, tests it and sells it again.

Reprocessors are manufacturers

The Federal Food, Drug, and Cosmetic Act defines a single-use device as one "intended for one use, or on a single patient during a single procedure." A reprocessed device is one that has been used on a patient and then put through "additional processing and manufacturing" for another single use, according to FDA's frequently asked questions on reprocessed single-use devices.

FDA says hospitals began reprocessing such devices in the late 1970s to save money and cut waste. The agency regulates third-party reprocessors and hospitals that reprocess in the same way as the original equipment manufacturer. That means a reprocessor must register with FDA, follow the quality system rules in 21 CFR Part 820, report adverse events under the medical device reporting rule, and meet labeling and premarket requirements. Reprocessed devices must also carry the statement "Reprocessed device for single use. Reprocessed by" followed by the name of the reprocessor.

What a reprocessing 510(k) must show

The Medical Device User Fee and Modernization Act of 2002 added section 510(o) to the law, FDA's guidance on validation data for reprocessed devices explains. For device types FDA has listed, a reprocessor's 510(k) must include validation data on cleaning, sterilization and functional performance showing the device stays substantially equivalent to a predicate "after the maximum number of times the device is reprocessed as intended by the person submitting the premarket notification." The predicate can be the original manufacturer's device or any device of that type.

The law also sorted reprocessed devices by risk. A critical device contacts normally sterile tissue or body spaces; a semi-critical one contacts intact mucous membranes. FDA reviewed reprocessed critical and semi-critical devices that had been exempt from 510(k) review and, in notices from 2003 to 2005, ended the exemption for some device types, the guidance says. Reprocessors of those types had to file 510(k)s with validation data or stop selling them.

The data must cover the whole process. FDA's FAQ says reprocessors should show that a device can be adequately cleaned and disinfected or sterilized, that its physical characteristics or quality are not harmed by those steps, and that it continues to meet FDA requirements after each cycle. That is why a clearance names a number of uses: the validation data must support each one. Innovative Health said each clearance requires "extensive reverse engineering, coding, cleaning research and validation" and new testing and inspection procedures.

Where the rules stop

Not every reprocessed device needs a premarket review. Devices that did not need one originally generally still do not, unless FDA has ended the exemption for that type. Reprocessed class III devices need a premarket report to support premarket approval, FDA says. The 2006 guidance adds that a reprocessor whose device type needs validation data should not use the shorter Special 510(k), because that route does not include the data. The same rules apply to original manufacturers if they reprocess their own single-use devices.