FDA requirements for Servicing and Refurbishment of Medical Devices

[cscalise]

Can anyone point me in the direction of FDA regulations or guidance documents regarding organizations that provide services to refurbish or service medical devices. Thanks!

 

[Ronen E]

The requirements depend on the nature of actions taken. Please try to describe what is done in more detail. Thanks.

 

[Mark Meer]

The general quality system regulations are in Subpart N of 21 CFR 820 regulations (specifically part 820.200).

You can review these regulations here.

 

[cscalise]

Thank you. I am familiar with this section. What if the organization is not the original manufacturer but a service provider that refurbishes and services medical devices?

 

[Mark Meer]

What if the organization is not the original manufacturer but a service provider that refurbishes and services medical devices?

In this case, it is the responsibility of the manufacturer to exercise appropriate controls on you (as a contracted service).

If the manufacturer hasn't:
- sufficiently evaluated your procedures/practices/documentation, or audited your facilities/system; and/or
- prescribed procedures to you (which presumably they will monitor/audit)
...then I'd be concerned (more for the manufacturer than for yourself...)

Bottom line, however, is that:
- The manufacturer has decided to include servicing of their devices and decided to outsource the servicing activities to you.
- You, as a contractor, have no regulatory obligations...only (presumably) contractual obligations with the manufacturer.

 

[cscalise]

I also found CPG Sec. 300.200 - Reconditioners/Rebuilders of Medical Devices - Revoked-Deletion 01/04/2000 which didn't help much and CPG 300.500 but that is for single use device. I am more interested in medical/laboratory equipment (ie instrumentation, processing equipment, etc.)

 

[Ronen E]

In this case, it is the responsibility of the manufacturer to exercise appropriate controls on you (as a contracted service).

If the manufacturer hasn't:
- sufficiently evaluated your procedures/practices/documentation, or audited your facilities/system; and/or
- prescribed procedures to you (which presumably they will monitor/audit)
...then I'd be concerned (more for the manufacturer than for yourself...)

Bottom line, however, is that:
- The manufacturer has decided to include servicing of their devices and decided to outsource the servicing activities to you.
- You, as a contractor, have no regulatory obligations...only (presumably) contractual obligations with the manufacturer.

This is not necessarily true, especially if refurbishment (in the proper sense) is included. I think you made too many assumptions.

 

[Ronen E]

I also found CPG Sec. 300.200 - Reconditioners/Rebuilders of Medical Devices - Revoked-Deletion 01/04/2000 which didn't help much and CPG 300.500 but that is for single use device. I am more interested in medical/laboratory equipment (ie instrumentation, processing equipment, etc.)

You still haven't explained the exact nature of the actions taken, or the legal nature of your relationship with the manufacturer(s) of the equipment.

 

[MIREGMGR]

There is a gray line between "refurbisher" and "remanufacturer". My understanding is that FDA in practice considers the former term to apply to a company that obtains used equipment, cleans it up and re-markets it to a new user; with the latter applying to a company that performs repairs to equipment that is significantly out of original performance or safety specs, so as to bring it into those original specs, or new specs that make it clinically safe and effective in some different manner.

If your role will fit the "remanufacturer" definition, then very generally in the absence of further information about your company, your responsibilities will be:

1. Register.
2. List all the devices you will work on.
3. Set up and maintain a QMS, including all of the actions needed for your organization under that QMS to be conforming.
4. If the devices you work on are radiation emitting, file the appropriate reports.

 

[MIREGMGR]

- The manufacturer has decided to include servicing of their devices and decided to outsource the servicing activities to you.
- You, as a contractor, have no regulatory obligations...only (presumably) contractual obligations with the manufacturer.

If the actions to be taken fit the definition of "remanufacturer", I think the second part of the quoted statement is incorrect. My understanding is that the party conducting remanufacturing activities is responsible for those activities, and there is no category of "contract remanufacturer".