Medical Device Interfaces are Subject to FDA Rules, Says IT Expert

In February, the FDA issued an important rule on Medical Device Data Systems (MDDSs), categorizing them as subject to FDA Class I general controls. MDDSs are data systems that transfer, store, convert according to preset specifications, or display medical device data without controlling or altering the function or parameters of any connected medical device–that is, any other device with which the MDDS shares data or from which the MDDS receives data. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq.) establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) establishes three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval). General controls include requirements for registration, listing, adverse event reporting, and good manufacturing practice (quality system requirements) (21 U.S.C. 360c(a)(1)(A)). Special controls are controls that, in addition to general controls, are applicable to a class II device to help provide reasonable assurance of that device’s safety and effectiveness (21 U.S.C. 360c(a)(1)(B)).