The Food and Drug Administration (FDA) requested comments on March 4 regarding definitions and possible regulations governing medical device refurbishers, reprocessors, and other third parties.
Medical device manufacturers have the duty, under 21 C.F.R. Part 820, to provide instructions to third parties that may service or install their products. However, manufacturers may not be able to maintain control over their device after it leaves their hands, which can be a problem especially if the device is not repaired correctly or a third party changes the product. Stakeholders expressed concerns regarding the safety and effectiveness of medical devices that undergo one or more activities by a third party. FDA proposed adding seven definitions for third parties and the activities they perform on already-manufactured medical devices:
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Recondition: Restores and/or refurbishes a medical device to the OEM’s original specifications. Under limited circumstances the medical device may be restored and/or refurbished to current specifications.
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Service: Maintenance or repair of a finished device after distribution to return it to the safety and performance specifications established by the OEM and to meet its original intended use. Servicing cannot change the intended use(s) of the device from its original purpose(s).
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Repair: Return the device or component to original specifications including replacing non-working components or parts outside of routine or periodic upkeep for the current owner of the device.
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Refurbish: Restore device to a condition of safety and effectiveness that is comparable to when new. This includes reconditioning, repair, installation of certain software/hardware updates that do not change the intended use of the original device, and replacement of worn parts.
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Remanufacture: Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device’s performance, safety, specifications, or intended use.
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Remarket: The act of facilitating the transfer of a previously owned device from one party to another by sale, donation, gift, or lease.
The FDA also invites interested parties to comment on the benefits and risks related to the definitions and on the following:
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Who are the different stakeholders involved with the medical device activities listed previously? What are their respective roles?
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What evidence exists regarding actual problems with the safety and/or performance of devices that result from these activities? Specific examples should be submitted.
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What are the potential risks (patients/users) and failure modes (devices) introduced as a result of performing the previously defined activities on medical devices? Please speak to issues common to all devices as well as specific risks with specific devices.
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These activities are performed by OEMs and various third-party entities, including hospitals and humanitarian organizations. Are the risks different depending on who performs the previously mentioned activities?
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We [FDA] are interested in knowing if these activities are more difficult or riskier to perform on certain devices versus others. Please cite specific examples in your response, along with an explanation of the source of this particular complexity.
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What information do third-party entities need in order to perform these activities in a way that results in safe and effective operation of the medical device? Please provide specific examples.
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What additional challenges to stakeholders encounter with devices that result from these activities?
Comments are accepted until May 3, 2016. Interested parties can comment electronically on regulations.gov, or send their written comments to FDA at: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Make sure to cite Docket Number FDA-2016-N-0436 when sending written comments. Interested parties can also contact the authors of this post to discuss how they may be affected by potential regulations.
International Note on Third Parties’ Regulatory Responsibilities: The New Legislative Framework in the EU, the principles of which guide the proposed EU Medical Device and IVD Regulations, also includes regulatory responsibilities for third parties in the medical device and IVD distribution chains.
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