Understanding FDA rules regarding MDDS Status and Clinical Trials

S

susanb

#1
I'm hoping someone out there can help me understand FDA rules regarding MDDS status and clinical trials. I've tried searching this topic six ways to Sunday, and can't find a definitive answer.

Let's say there is an organization that is part of a hospital network, and is involved in a clinical trial. In the trial, radiology images are stored locally, along with pertinent patient data and tumor measurements made on the associated images. The data is stored in a database, but otherwise not manipulated by the site. The data is used by trial sponsors - not the hospital - to determine courses of therapy for research purposes.

Is this organization within the hospital required to file as a MDDS? Or does the FDA exempt clinical trials from the need to file as a device manufacturer or data system, provided the organization meets all GMP and GCP audits by trial sponsors?

Does this answer change if the hospital expands its operation to include health centers not under the parent's umbrella?

Any information you might provide would be greatly appreciated. Thanks!
 
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yodon

Staff member
Super Moderator
#3
I'll try to get the ball rolling... but I had trouble following the organization so let me ask some questions first.

Who is the 'manufacturer of record' of the MDDS?

Does the using organization modify it in any way?

Is it only used for (a single) clinical trials?

Reading the rule:

http://www.fda.gov/MedicalDevices/P...pplies/MedicalDeviceDataSystems/ucm251927.htm

triggered the above questions. In that link, it describes who is a 'manufacturer' and when someone is not. Don't know if that helps or not.
 
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