FDA should stop calling medical devices remanufactured when they are not
We urge the US Food and Drug Administration (FDA) to stop using the term “remanufacturing” to identify a process that “significantly changes the finished device’s performance or safety specifications, or intended use”.
While we recognise the regulatory need for the FDA to identify a process that could negatively modify an existing device, calling it “remanufacturing” contradicts the commonly accepted definition published by the US International Trade Commission (USITC).
According to the USITC, remanufacturing is “an industrial process that restores end-of-life goods to original working condition or better”.
Remanufacturing – a key driver of a circular economy – represents an important and growing segment of US manufacturing. The USITC definition of remanufacturing is widely recognised across key industry sectors.
It appears in federal legislation and is used by other government agencies, including the Office of the United States Trade Representative (USTR), US Customs and Border Protection (CBP), and the US Federal Trade Commission (FTC).
Different industry sectors use different terms to identify the remanufacturing process – and that is completely acceptable – as long as that sector’s term refers to “an industrial process that restores end-of-life goods to original working condition or better”.
For instance, in the automotive and commercial vehicle sectors, the term is remanufacturing itself; in aviation and aerospace, the reference is maintenance, repair and overhaul (MRO); and for consumer goods and electronics, the term is refurbishing.
According to the USITC, “Finally, most US remanufacturers of medical imaging equipment identify themselves as refurbishers rather than remanufacturers because of the specific regulatory definition of ‘remanufacturer’ provided by the US Food and Drug Administration.”
As noted, the remanufacturing process is significantly different than how it is represented by the FDA; therefore, another term is needed by the FDA to properly identify a device that has been altered and no longer complies with its reported, intended use.
Calling this “remanufacturing” is inaccurate, misleading to consumers and a risk to patient safety. In essence, we are simply asking the FDA to call it something else.
MEMA and MERA urge the FDA to recognise today’s commercial reality and no longer use the term “remanufacturing” when referring to a modification process that “significantly changes the finished device’s performance or safety specifications, or intended use”. By doing so, the FDA will align with other government agencies and industry sectors; curtail confusion among consumers; lower the risk to patient safety; and advance the US economy and international trade.
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