FDA issues long-awaited device remanufacturing guidance

The US Food and Drug Administration (FDA) has published its final guidance on the remanufacturing of medical devices, adding a new section on regulatory requirements that clarifies remanufacturers are subject to investigations and inspections by the agency.

“Today’s action represents an important step forward in our mission to assure continued patient access to high-quality, safe and effective medical devices,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, stated in an agency news release. “This guidance provides important clarity on defining remanufacturing and helps to remove perceived barriers to obtaining repair or maintenance of a device if it does not alter the safety, performance or intended use.”

The goal of the final guidance is to help industry and other entities understand how the agency views the difference between servicing and remanufacturing of medical devices. FDA said servicing involves “repair and/or preventive or routine maintenance of one or more parts in a finished device” following its distribution with the intent of restoring it to the original equipment manufacturer’s (OEM’s) original use as a legally marketed device. Remanufacturing “significantly changes the finished device’s performance or safety specifications” beyond the OEM’s original intended use as a legally marketed device through processing, conditioning, renovating, restoring, repackaging, or other acts, the agency explained.

FDA said it looks at the activities an entity performs on a device to determine whether that entity is a servicer or remanufacturer regardless of how the entity identifies itself. “The determination of whether the activities an entity performs are remanufacturing affects the applicability and enforcement of regulatory requirements under the [Federal Food, Drug, and Cosmetic Act] FD&C Act and its implementing regulations,” they wrote.

Industry’s concerns

The agency has been engaged with industry and the public since 2016 on the topic of distinguishing between servicing and remanufacturing of medical devices, first opening a docket for public comment and holding a public workshop, and ultimately issuing a report on the medical device servicing quality, safety, and effectiveness in 2018. In the paper, FDA acknowledged that most clinical adverse events and deaths reported to the agency were misclassified as inadequate servicing when they should have been classified as remanufacturing, and the agency resolved to create guidance surrounding this topic for clarity.

After FDA released the draft guidance in 2021, they received numerous comments from industry and other stakeholders concerned about the agency’s focus on OEMs over third-party servicers and other entities that might contract with OEMs, with some stakeholders arguing third-party servicers shouldn’t be included at all.

AdvaMed told FDA in their comment responding to the draft guidance that the agency should simplify the guidance for third-party manufacturers that often contract with OEMs and may not be familiar with regulatory requirements and terminology in the guidance, including servicers that are trained by OEMs, OEMs that service their and other manufacturers’ devices, and OEM-trained biomedical engineers in hospitals.

“It is recommended FDA acknowledge and consider the range of service organizations involved in servicing and remanufacturing,” they said.

The Alliance for Quality Medical Device Servicing said FDA should consider all independent service organizations (ISOs) and healthcare delivery organizations (HDOs) that engage in device remanufacturing, not just non-OEM ISOs labeled as third-party contractors. “We urge the FDA to revise this guidance to state that that it applies to any entities engaging in these activities,” they wrote.

Additionally, the Alliance for Quality Medical Device Servicing cited the “significant change” component of the agency’s definition of remanufacturing, noting it “can be subjective and subject to significant discretion.”

However, the Medical Imaging & Technology Alliance (MITA) said it is concerned by FDA’s reliance on third-party servicers and ISOs “who are not regulated by the FDA; who do not seek out nor follow FDA policy, regulations or guidance; whose activities regarding medical devices are unregistered and therefore unknown to the FDA; who have not established quality management processes and documented procedures; and who do not report device malfunctions resulting from their servicing activities.”

MITA said these entities are not required to comply with the guidance. “Until FDA removes its enforcement discretion, requires all third-party servicers and ISOs to comply with registration, regulatory, quality and safety requirements, and proactively exercises appropriate oversight (i.e, inspections) and enforcement policies, the current servicing activities actually constituting unregulated remanufacturing of medical devices will continue,” they wrote.

The Medical Device Manufacturers Association (MDMA) raised a concern in their comment that servicing instructions and functional specifications in device labeling “are not intended to encourage the disclosure of trade secrets or confidential commercial information” be moved up from a footnote to be included in the final guidance proper. “MDMA does not support any effort to compel the disclosure of trade secrets or confidential commercial information,” they said. MDMA also brought up the issue of remaining compliant with cybersecurity requirements for devices that have been serviced by an OEM, third-party manufacturer, or other entity.

The Association of Medical Device Service Organizations, raised a concern in their comments that, for entities to implement the guidance, OEMs would need to make specifications, parts, components, and materials available to servicers and remanufacturers of medical devices. “Currently, there is no requirement for OEMs to provide such information or materials to the device owner (e.g., a hospital) or to third party ISOs,” they wrote.

Final guidance

FDA said the final guidance contains several revisions based on comments to the draft guidance, including clarification on activities that constitute a remanufacturing of a device, applicability to OEMs and external entities contracted by OEMs.

In the new section on regulatory requirements for remanufacturers of medical devices, FDA said “remanufacturers are considered manufacturers under the FD&C Act and FDA’s regulations, and are thus regulated as such.”

“Entities that are remanufacturing devices, including devices that they did not originally manufacture, are generally subject to the same regulatory requirements as the OEM of the device,” they wrote.

This means that remanufacturers can also be inspected and investigated by the agency to comply with the FD&C Act, FDA noted. “When a medical device manufacturer, including a remanufacturer, fails to comply with the FD&C Act and its implementing regulations, FDA has the authority to respond with enforcement tools,” they said.

In addition, remanufacturers need to have their own device listing independent of the OEM device listing as well as their own establishment registration if they have not been registered as a device manufacturer, the agency said. Remanufacturers also are required to comply with premarketing requirements such as obtaining marketing authorization prior to remanufacturing activities, submit a written report to the agency for Medical Device Reports of Correction and Removals, have a quality system in place for the remanufactured device, and are subject to Medical Device Reporting requirements.

If a remanufactured device significantly deviates from the OEM label, it likely also needs a corresponding label change, FDA said. OEMs should also provide remanufacturers with the information they need to return a device to its original performance and safety specification, they noted.

“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. FDA’s recommendations are not intended to encourage the disclosure of trade secrets or confidential commercial information,” they said.

Guidance

Federal Register notice

FDA issues long-awaited device remanufacturing guidance

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