There are other implications, including the impact of this legislation, if approved, on the FDA proposed rulemaking involving 21 CFR 820 and ISO 13485. Three weeks ago, the FDA published in the Federal Register its intention to amend the current good manufacturing practice requirements and included an invitation for comment on the FDA proposed regulation.

But apparently some are not willing to await public comment and consideration of the about-to-be-published FDA Guidance as well as the above-referenced new FDA regulation — preferring instead to ask Congress to intercede. This legislation may be sending another message which has implications for industry competition. As former EP Radiological Services Inc. president and CEO, Richard Flannery commented, “FDA regulatory changes should be, first and foremost, about patient safety.”
Expanding the definition of 'remanufacturing' without justification
Notably, under this trade association proposed legislation, the definition of "remanufacturer" includes activities undertaken by a person other than the manufacturer that "could" change the performance, safety specifications, or intended use of the equipment. A long list of possible "remanufacturing" activities would include replacement parts and module compatibility, cybersecurity, software, use of non-conforming parts and bypassing access protections or technological protection measures. All of this would possibly be considered to be "remanufacturing" if this legislation is allowed to proceed.

ECRI Vice President Emeritus Mark Bruley, whose substantial ECRI analysis was relied upon in the 2018 FDA Servicing Report to Congress noted that regulatory changes in the FDA area “should be evidence-based”. Nothing in the proposed legislation details why the legislation is necessary in light of the FDA initiatives or how these denoted activities bear any relation to the current concept of "remanufacturing" — which requires a “significant” change to a device or system.

Indeed, the legislation would drop the requirement of "significant" changes from the existing FDA definition altogether. This may be seen by a review of the existing FDA Remanufacturing Regulation definition found at 21 CFR 820.3(w). It provides that a remanufacturer “is any person who processes, conditions, renovates, repackages, restores or does any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use.”

“How does one evaluate when a non-significant activity falls within the rubric of this proposed legislation?" said IAMERS president Diana Upton. "I am concerned that the net effect on the healthcare system might well be to reduce the availability of refurbished equipment and/or increase the cost, with limited to no potential benefit for patient safety.”

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