IDE

Question 1

True or False. FDA Form 1572 is required for all trials.

Answer 1

False. Form 1572 is required for IND studies but not required for IDE. A generic doctor agreement is all that is required for IDE.

Question 2

What types of devices are considered IDE exempt?

Answer 2

• In commercial distribution before May 28, 1976
• Diagnostic device that is noninvasive, does not require invasive sampling, does no introduce energy into the subject and requires the confirmation of another medically established diagnostic product.
• Device undergoing consumer preference testing, testing a modification or testing a combination of 2 marketed devices with no risk to the patient
• Device for veterinary use.
• Research only devices

Question 3

What does CAPA stand for?

Answer 3

Corrective and Preventative Action Plans

Question 4

What is an Unanticipated adverse device effect?

Answer 4

Any serious adverse effect on health or safety including life-threatening problem or death that is not anticipated or not previously identified with the use of the device.

Question 5

True or False. The sponsor is allowed limited promotion and testing of an investigational device prior to FDA approval.

Answer 5

False, FDA must approve the device for commercial distribution first.

Question 6

What is a siginificant risk device?

Answer 6

Device that is:

• Intended as an implant and presents potential for serious risk to patient
• Will be used to sustain human life
• Critically important in diagnosing, curing, mitigating or treating serious diseases

Question 7

What is treatment use of an investigational device?

Answer 7

The sponsor can apply for a treatment IDE where the device can be used in treatment of patients who aren’t in the clinical trial. This is typically done in serious or life-threatening diseases/conditions where no other alternatives are available to benefit these patients.

Question 8

What records should the investigator retain during an IDE trial?

Answer 8

• All correspondences with other investigators, sponsor, IRB, monitor or FDA.
• Records of receipt, use or disposition of the device
• Records of each subjects case history and exposure to the device (CRF, consent forms, medical records, etc.)
• The trial protocol

Question 9

What records should the sponsor retain during an IDE trial?

Answer 9

All correspondences with other sponsors, monitors, investigators, IRB or FDA.

• Records of device shipment and disposition including batch numbers, dates, quantities, etc.
• Signed investigator agreements and financial disclosure information
• Trial information including investigators, IRB used, device risk designation, device use, etc.
• Any adverse event records

Question 10

When an unanticipated adverse device effect occurs, what needs to be done by the investigator?

Answer 10

Submit a report to the sponsor and IRB within 10 working days.

Question 11

True or False. If the investigator uses the device without informed consent, they have 10 working days to report it to the sponsor and IRB.

Answer 11

False. They have 5 working days to report it to the sponsor and IRB.