By Bill Finerfrock, Capitol Associates
The Food and Drug Administration (FDA) has announced that the agency will be holding a public workshop on October 27th and October 28th entitled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers.” As many AHRA members work in facilities or departments that may use or consider using certain equipment that would fall into this category, we thought you might like to know more about this upcoming workshop. The workshop will begin at 8:30 AM on October 27 and goes to 5:00 PM. The workshop will resume at 8:30 AM on October 28 and is scheduled to end at 4:00 PM.
We recognize that most AHRA members will not be inclined to attend in-person. However, the workshop will be webcast. The webcast link will be available on the registration web page after October 20.
If you or a member of your staff would like to attend in person, the workshop will be held at:
FDA White Oak Campus
10903 New Hampshire Ave.
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, MD 20993-0002
Registration is free and available on a first-come, first-served basis. Persons wishing to attend must register online by September 23 at 4:00 PM; early registration is recommended. Click here to register for the workshop. Registrants will receive confirmation after they have been accepted or waitlisted.
The topics to be discussed include the current regulatory environment for these activities, the definitions of the various terms FDA proposed in the prior Federal Register notice on this subject, and whether these activities should appropriately be regulated by FDA or a non-governmental organization.
The workshop sessions will incorporate the following general themes pertaining to the refurbishing, reconditioning, rebuilding, remarketing, remanufacturing, and servicing of medical devices:
- Establish working definitions for third-party and 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.
The workshop will include a public comment session and topic-focused sessions.
For further information, contact Felicia Brayboy of the FDA’s Center for Devices and Radiological Health at: Felicia.Brayboy@fda.hhs.gov.
Bill Finerfrock is the president and owner of Capitol Associates, a government relations/consulting firm. Prior to assuming ownership of Capitol Associates, Bill was a senior vice president in the company for more than 20 years. Capitol Associates was selected to work with AHRA on their regulatory affairs issues. Bill specializes in health care financing, health systems reform, health workforce and rural health. He can be reached at email@example.com.