Medical Device Data Systems

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Medical Device Data Systems | FDA

https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/medical-device-data-systems

Medical Device Data Systems (MDDS) are hardware or software products intended to transfer, store, convert formats, and display medical device data. A MDDS does not modify the data or modify...

Identifying an MDDS | FDA

https://www.fda.gov/medical-devices/medical-device-data-systems/identifying-mdds

The electronic transfer or exchange of medical device data from a medical device, without …

Medical Device Data Systems, Medical Image Storage …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-data-systems-medical-image-storage-devices-and-medical-image-communications-devices

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Guidance for Industry and Food and Drug …

MDDS Rule | FDA - U.S. Food and Drug Administration

https://www.fda.gov/medical-devices/medical-device-data-systems/mdds-rule

CDRH may decide to classify such a device as Class I (requiring general controls), Class II (requiring special controls), or Class III (requiring premarket approval). Risks associated …

Medical Device Data Systems, Medical Image …

https://www.fda.gov/media/88572/download

A device that receives and/or displays information, alarms, or alerts from a monitoring device in a home setting and is intended to alert a caregiver to take an immediate clinical action....

Medical Device Databases | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

Apr 6, 2022

Requirements for Health Care Facilities and …

https://www.fda.gov/medical-devices/medical-device-data-systems/requirements-health-care-facilities-and-manufacturers

Purchasing and using an MDDS marketed by an MDDS manufacturer for purposes of interfacing with medical devices and performing functionality described in the MDDS rule …

Step 5: Transferring, Storing, Converting, or Displaying …

https://www.fda.gov/medical-devices/digital-health-center-excellence/step-5-software-function-intended-transferring-storing-converting-formats-or-displaying-data-and

Software functions that are solely intended for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results …

What is an MDDS (medical device data system)?

https://www.cardiac-devices.com/what-is-an-mdds-medical-device-data-system/

A medical device data system (MDDS) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical …

eCFR :: 21 CFR 880.6310 -- Medical device data system.

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-880/subpart-G/section-880.6310

( 1) A medical device data system (MDDS) is a hardware device that is intended to provide one or more of the following uses, without controlling or altering the functions or …

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