Now that the commenting period has ended, the FDA plans to host a two-day public workshop for stakeholders to discuss the questions raised in its third-party service and refurbished medical device docket.

In March, the FDA introduced a docket that sets out to specifically define terms pertaining to the non-OEM medical industry. Interest in it, sparked by safety concerns, has sent shock waves through a third-party industry eager to defend its reputation and fearful of regulations that might hurt its business.

For OEMs the docket is generally regarded as an opportunity to gain greater clarity about what they can and cannot be held accountable for in situations where a third-party has taken over control of their machinery.

The workshop, to be held on October 27 and 28 at the FDA's campus in Silver Spring, Maryland, will aim to move the needle on issues central to the docket:

• Establish working definitions for third-party and (original equipment manufacturer) OEM activities.


• Discuss benefits and challenges that stakeholders encounter, potential benefits and risks to patients/users, and failure modes of devices introduced as a result of performing activities associated with third-party entities.


• Identify current best practices and discuss alternative methods to mitigate risks associated with performing activities associated with third-party entities.


• Determine whether specific procedures are necessary for each activity as it relates to third-party services performed.

“FDA is currently reviewing all of the comments and will use them to inform a set of working questions designed to promote an understanding of challenges and best practices to mitigate risks associated with these activities,” said the FDA in the Federal Register.

The docket received 176 comments from a wide range of stakeholders. Look for the August issue of HealthCare Business News magazine for an in-depth report on those responses.

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