1
Q
Device categories Exempt from IDE application
A
- devices in commercial distribution
- Diagnostic devices that are not invasive
- Device testing not for safety or efficacy and does not put subject to risk.
- Veterinary use devices
- Devices for animal lab research and labeled as such
- Custom devices
2
Q
The FDA may grant waiver for some or all IDE requirements if
A
The waived requirements are not necessary to protect the rights, Safety, or welfare of subjects.
3
Q
IDE application required for
A
- SR devices.
- Study device w/ an exception to ICF
- FDA request application.
4
Q
Requirements for IDE exception submission:
A
- Must submit 3 signed copies of “Application for an investigational device exception”
- Separate IDE required for studies involving IC exceptions
5
Q
Contents of IDE application
A
- Name and address of sponsor
- Complete report of prior investigations of device w/ investigational plan summary.
- Manufacturing information to support quality control.
- Sample agreements w/ investigators.
- Complete accurate list of participating investigators.
- IRB and institution
- Amount charged for device
- Copies of labeling and info to be provided to subjects.
6
Q
IDE investigational plan to include
A
- Name and use of device.
- CI duration with objectives
- Protocol w/ methodology for sci analysis.
- Risk analysis with mitigation factors and subject population
- Description of device
- Written procedures for monitoring investigation.
- Copies of device labeling and ICF materials
- Participating IRBs, CIs, and description of records and reports to be maintained.
