An op-ed by Robert J. Kerwin

Yesterday the FDA released its final guidance to provide the medical device industry clarity on the definition of "remanufacturing" for reusable devices needing maintenance or repair, a lingering point of ambiguity in an overarching discussion about right-to-repair.

A draft of the guidance was initially released for comment and consideration back in 2021, at which time we outlined key points of the document.

In large part, the final guidance appears to restate the draft guidance on key sections.

One notable section containing similar language to the draft is "Labeling", which begins on page 20 of the guidance. Under the Federal Food Drug & Cosmetic Act, labeling is not simply the display of written, printed or graphic matter, but encompasses “all labels and any written, printed or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.” Labeling has been interpreted to mean anything that accompanies a device or "supplements or explains" a product.

In the final guidance section on Labeling, the FDA notes the need for devices to routinely undergo both preventive maintenance and the need for repair information. The guidance states: “[I]t is important that such devices include instructions on how to adequately return a device to its performance and safety specifications established by the OEM.” The language of the guidance is less mandatory and more discretionary, (page 21):

Consistent with promoting and protecting the public health, FDA encourages OEMs, as an industry best practice, to provide servicing instructions that facilitate routine maintenance and repair of their reusable devices.

Given the reluctance of some manufacturers to cooperate in this regard (as acknowledged in the 2021 FTC Report "Nixing the Fix"), there is little reason to think OEMs will be receptive to this "encouragement".

The FDA guidance incorporated a helpful list from its draft of just exactly what the "labeling" ought to include to facilitate routine device maintenance and repair:

• A description of the key performance and safety specifications
• Critical technical or functional specifications, including:
  • Physical dimensions
  • Electrical characteristics, including batteries (e.g., chemistry, amperage, voltage, rechargeability), internal fuses, and power supply (e.g., voltage, amperage, frequency); and
  • Device-specific performance specifications (e.g., flow rate accuracy or range, humidity, temperature, wavelength).
• The recommended maintenance activities and schedule
• Recommended troubleshooting steps, routine testing, and acceptance criteria to confirm that the device remains within its performance and safety specifications’
• A description of error codes, alerts, and alarm features on the device
• Precautions, and warnings relevant to servicing the device; and
• Version number and release date of software.

While the listing is useful and comports with many of the service access requests of independent servicing organizations, by itself, it offers few solutions on right-to-repair.

Moreover, the other FDA statements incorporated from the Labeling section of the draft guidance are concerning: “[u]nintentional remanufacturing can occur when entities do not have the instructions necessary to return a device to its original performance and safety specifications.” It will be interesting to observe whether some OEMs elect to continue withholding adequate service access information and thereafter, citing the final guidance, allege that independent servicers are engaged in remanufacturing as they are not provided adequate service access information. We hope this concern is greatly misplaced.

About the author: Robert J. Kerwin is the general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers.