IDE Application

Question 1

Device categories Exempt from IDE application

Answer 1

1. devices in commercial distribution
2. Diagnostic devices that are not invasive
3. Device testing not for safety or efficacy and does not put subject to risk.
4. Veterinary use devices
5. Devices for animal lab research and labeled as such
6. Custom devices

Question 2

The FDA may grant waiver for some or all IDE requirements if

Answer 2

The waived requirements are not necessary to protect the rights, Safety, or welfare of subjects.

Question 3

IDE application required for

Answer 3

1. SR devices.
2. Study device w/ an exception to ICF
3. FDA request application.

Question 4

Requirements for IDE exception submission:

Answer 4

1. Must submit 3 signed copies of “Application for an investigational device exception”
2. Separate IDE required for studies involving IC exceptions

Question 5

Contents of IDE application

Answer 5

1. Name and address of sponsor
2. Complete report of prior investigations of device w/ investigational plan summary.
3. Manufacturing information to support quality control.
4. Sample agreements w/ investigators.
5. Complete accurate list of participating investigators.
6. IRB and institution
7. Amount charged for device
8. Copies of labeling and info to be provided to subjects.

Question 6

IDE investigational plan to include

Answer 6

1. Name and use of device.
2. CI duration with objectives
3. Protocol w/ methodology for sci analysis.
4. Risk analysis with mitigation factors and subject population
5. Description of device
6. Written procedures for monitoring investigation.
7. Copies of device labeling and ICF materials
8. Participating IRBs, CIs, and description of records and reports to be maintained.