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FDA explains when device 'servicing' becomes 'remanufacturing'

Posted 17 June 2021 | By Kari Oakes 

FDA explains when device 'servicing' becomes 'remanufacturing'

At what point does manipulation or repair of a medical device cross the line from “servicing” to “remanufacturing?” A new draft guidance from the US Food and Drug Administration (FDA) provides a set of considerations to aid in determining into which category actions performed on devices should fall.
 
The new draft guidance “helps clarify whether activities performed on devices are likely remanufacturing,” wrote FDA’s Center for Devices and Radiological Health (CDRH) in announcing its availability. The guidance is intended to clarify, rather than to change, the regulatory requirements to which remanufacturers must adhere. “It is not intended to adopt significant policy changes,” according to CDRH.
 
Over the past several years, FDA has asked for input on how the agency might distinguish between servicing and manufacturing of medical devices, soliciting perspectives via comments on a public docket, and holding a public workshop in 2016.
 
The agency also published a report on device servicing in 2018, which “concluded that a majority of the comments, complaints, and adverse event reports received by the Agency that referred to inadequate ‘servicing’ causing or contributing to adverse events and deaths actually pertained to ‘remanufacturing,’” according to the guidance. That same year, FDA issued a white paper, again opened a public docket, and held another public workshop “to facilitate public discussion” on this distinction. (RELATED: Refurbished medical devices: FDA wants to hear more from industry, Regulatory Focus 03 March 2016; CDRH turns down industry call for regulatory controls over third-party services, Regulatory Focus 15 May 2018)
 
The main body of the new draft guidance runs to 17 pages and is accompanied by two appendices that give examples of component, part, material and software activities that might or might not be considered remanufacturing, as well as examples of documentation.
 
Key to the guidance’s explanation of FDA’s thinking on the issue is a one-page flowchart. One factor that that makes it more likely that an activity constitutes remanufacturing include changes, including addition or removal, to device components that either directly or indirectly contact body tissue, and that this manipulation results in significant changes to device performance or safety specifications.
 
If the first criterion has not been met, but changes affect the dimensional or performance specifications of a component, part or material of the device and the performance or safety specifications are changed significantly, the activity is also likely remanufacturing, according to the flow chart.
 
Similarly, if neither of the first two criteria are met, but a new or modified risk is identified and the device performance or safety specifications are significantly changed, the activity is likely to be considered remanufacturing by FDA.
 
In the draft guidance, FDA notes that the decision path in the flowchart does not include all considerations outlined in the guidance. Also, the chart should only be used “after an entity determines that there is no significant change to intended use or the device’s sterilization methods, reprocessing instructions, control mechanism, operating principle, or energy type.”
 
The guidance also provides considerations for labeling of remanufactured devices.

Another new FDA document addresses how cybersecurity issues affect medical device servicing. The newly released discussion paper tackles four discrete areas, identifying how cybersecurity challenges and opportunities may affect how medical devices are serviced.
 
The paper reviews questions of privileged access and how to identify cybersecurity areas of vulnerability and, when they occur, incidents of security breaches. Also addressed are challenges and opportunities in the medical device product lifecycle, and how to prevent and mitigate cybersecurity vulnerabilities.
 
In addition to seeking public input on the specific topics addressed in the white paper, FDA also asks three questions:
  • What are the cybersecurity challenges and opportunities associated with the servicing of medical devices?
  • Are the four areas identified in this white paper the correct cybersecurity priority issues to address in the servicing of medical devices? If not, which areas should be the focus? and
  • How can entities that service medical devices contribute to strengthening the cybersecurity of medical devices?
 
FDA is hosting a 27 July webinar that will address both the draft guidance and the cybersecurity issues raised in the discussion paper. FDA is asking for public comments for each document within the next 60 days.
 
Draft guidance
Cybersecurity white paper
 

 

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