An “MDDS manufacturer” may be a health care facility or manufacturer that is engaged in the following activities:
Modifying a general purpose IT equipment/software or infrastructure for purposes of interfacing with medical devices and performing functionality described in the MDDS rule (transfer, store, display, or convert data).
Labeling a general purpose IT equipment/software as a MDDS for purposes of interfacing to medical devices and performing functionality described in the MDDS rule (transfer, store, display, or convert data).
Designing and implementing custom software or hardware for purposes of interfacing with medical devices and performing functionality described in the MDDS rule (transfer, store, display, or convert data).
The FDA does not consider the following activities to be “manufacturing” an MDDS:
Purchasing and using a general purpose IT equipment/software or infrastructure for purposes of interfacing with medical devices and performing functionality described in the MDDS rule (transfer, store, display, or convert data).
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 (transfer, store, display, or convert data).
