Device Interventions

Form shape

Device interventions use the shared intervention shell plus four additional sections.

Section	Fields
Basics	Name, Type, Sponsors, Description
Identifiers	Identifiers
Regulatory	FDA Device Classification, EU MDR Risk Class, SaMD Risk Level, Unapproved/Investigational Device
Science	Manufacturer, Intended Use, Implantable Device, Software/SaMD, Sterile Device, Combination Product, Active Device, Single-Use Device
Storage	Storage Category, Regulatory Reference, Min Temp, Max Temp, Target Temp, Temp. Unit, Light Sensitivity, Container Type, Shelf Life, Shelf Life Unit, Do Not Freeze, Do Not Refrigerate, Desiccant Required
Handling	Cold Chain Monitoring, Special Handling Requirements, Additional Handling Notes, Cold Chain Required, Validated Shipper Required

What is specific to device interventions

Device records combine regulatory classification with technical product characteristics.

Section	Label	Why it matters
Regulatory	FDA Device Classification	Captures FDA class I, II, or III framing
Regulatory	EU MDR Risk Class	Captures EU device risk class
Regulatory	SaMD Risk Level	Captures IMDRF software risk category when relevant
Regulatory	Unapproved/Investigational Device	Flags IDE-style investigational status
Science	Manufacturer	Ties the device to the responsible organization
Science	Intended Use	Explains intended clinical use and scope
Science	Implantable Device	Flags implant risk and follow-up implications
Science	Software/SaMD	Flags software-driven devices
Science	Sterile Device	Captures sterility expectations
Science	Combination Product	Flags device-plus-drug or biologic combinations
Science	Active Device	Flags energy-dependent devices
Science	Single-Use Device	Captures reuse expectations