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. Our ability to collect data directly from medical devices, reinforces this philosophy, and our belief that the best way to get the cleanest, highest quality PRO data is by getting closer to the patients than anyone else."

"We strive to make your ePRO experience a positive one," added Greg Gogates, VP Quality Management and Regulatory
Affairs." Our timely response to the new FDA regulation is just another way in which we ensure your clinical study will run as
smoothly as possible. Working with us means your clinical trials won’t be impeded by new industry requirements," he said.
"And, as always, our dedicated project managers will guide you through your study every step of the way, minimizing the risk
of delays and maximizing the chance of delivering your study on time."