- Version
- 1.0
- Length
- 6 pages
Abstract
Assess, rather than assume: a trial device’s regulatory status follows what it does, not what it is — and most assessments return a light-touch result that is then defensible. Teams most often misjudge the regulatory perimeter of the devices and systems a trial relies on. A participant’s phone is waved through as “just a phone”; a provisioned eCOA handset as “just the vendor’s phone”; a cleared spirometer or wearable as finished business because it is “already a device” — and the questions that actually attach get missed. One device or system can play several roles at once, so its obligations stack across seven regulated perimeters — medical device, GxP and computerized systems, data protection, human factors, configuration, economic operator and protocol design. They add up; they do not cancel out — and the stack differs per device and per deployment (Figure 1). What to do: for each device and system, establish its role, decide which perimeters it touches, record the controls and the reasoning, and reopen the assessment when the device, its software, its connection or the protocol changes. This primer names the seven perimeters and shows how the stack differs across three typical trial devices (Figure 1); Section 5 points to the paper that works each perimeter through, and QPP-00 — Regulatory Impact Assessment (RIA) sets out the method.
Contents
1. The moment a device or system carries trial data, regulatory questions attach to it; 2. A device’s regulatory status follows what it does, not what it is; 3. A trial device can fall into seven regulated perimeters at once; 4. Assess, rather than assume — and record the reasoning; 5. Start with QPP-00, then read the perimeters that match your devices and systems
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