The 21st Century Cures Act (12/13/2016) clarified FDA's regulation of medical software. The new law amended the definition of "device" in the Food, Drug and Cosmetic Act to exclude certain software functions.
The FDA is currently developing draft guidance for public comment to help industry and FDA staff understand how the 21st Century Cures Act affects FDA's oversight of medical device software. If you have questions about how the 21st Century Cures Act affects your products, or if you have comments on how the FDA should regulate medical software, please email email@example.com.
Medical Device Data Systems (MDDS) are hardware or software products that transfer, store, convert formats, and display medical device data. An MDDS does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device. MDDS are not intended to be used for active patient monitoring.
Examples of MDDS include:
- software that stores patient data such as blood pressure readings for review at a later time;
- software that converts digital data generated by a pulse oximeter into a format that can be printed; and
- software that displays a previously stored electrocardiogram for a particular patient.
The quality and continued reliable performance of MDDS are essential for the safety and effectiveness of health care delivery. Inadequate quality and design, unreliable performance, or incorrect functioning of MDDS can have a critical impact on public health.
For additional information, see "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices."