ARM 37.106.3321. INVESTIGATIONAL MEDICAL DEVICES

(1) An experimental treatment center that provides investigational medical devices must: (a) maintain specialized equipment and facilities appropriate for device implantation, monitoring, or administration; (b) establish device-specific informed consent procedures in addition to those required under 50-12-105, MCA. These procedures must address: (i) risks associated with device implantation and removal; (ii) long-term monitoring requirements; (iii) compatibility with other medical devices or treatments; and (iv) data collection, cybersecurity, and transmission capabilities of smart devices. (2) Experimental treatment centers administering investigational devices must have procedures in place for the following: (a) pre-procedure device inspection and calibration protocols; (b) device implementation; (c) post-procedure device monitoring and maintenance; (d) device malfunction reporting and response procedures; and (e) patient device registry and maintenance for long-term tracking. (3) Health care providers who administer investigational medical devices to patients must have documented training and demonstrated competency for device-specific procedures. Records must be maintained by the center’s administrator pursuant to ARM 37.106.3307. (4) The center must maintain a registry of all investigational medical devices administered to patients for a minimum of five years. The registry must include: (a) purpose of the treatment; (b) device identifiers; (c) patient outcomes; and (d) any adverse events. (5) For smart or internet-connected devices, the center must have policies and procedures addressing: (a) cybersecurity; (b) patient data privacy; and (c) patient access to device-generated data. (6) The center must have policies and procedures to address device malfunction, emergency removal, reporting of adverse events, and device or device part recalls. (7) Device performance and safety must be reviewed regularly as part of the center’s QAPI program in accordance with ARM 37.106.3315.