Medical Device Data Systems (MDDS)

Medical Device Data Systems (MDDS) are defined by the FDA as hardware or software that transfers, stores, converts, or displays medical device data. Medical Device Data Systems (MDDS) do not modify data, alter its display, or control any medical device functions. They also exclude active patient monitoring systems.

Key Functions of Medical Device Data Systems (MDDS)

An MDDS can:

• Electronically transfer medical device data

• Electronically store medical device data

• Convert data from one format to another

• Electronically display medical device data

However, Medical Device Data Systems (MDDS) must not change or interpret the data.

Device vs Non-Device MDDS

Under FDA regulations, Medical Device Data Systems (MDDS) may be classified as device MDDS or non-device MDDS depending on intended use and regulatory status.

What Is Not MDDS?

General-purpose hospital IT infrastructure operating within its original specifications is not considered Medical Device Data Systems (MDDS), even if it transfers, stores, converts, or displays medical device data.

Understanding Medical Device Data Systems (MDDS) is essential for regulatory compliance and proper FDA classification.