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In accordance with the new FDA regulation, set in April this year, CRF Health’s TrialMax® has become the first ePRO system to complete its Medical Device registration, a regulation that concerns medical device data systems (MDDS) that collect information from apparatus such as spirometers and glucometers.
TrialMax® is categorized as a Class 1 MDDS under regulation 21CFR 880.6310 (code OUG). And because it uses alarms to remind subjects when to take their study medication, it’s also classified as a ‘medication reminder’ under regulation 21CFR 890.5050 (code NXQ). This makes TrialMax® exempt from pre-market review but still subject to medical device 21CFR 820 quality standards, a practice to which CRF Health is fully compliant.
Rachael King, CEO explains, “CRF Health improves data collection by removing the barriers between intimate patient experiences and the technology designed to capture them.”