21 CFR Part 812

Question 1

What is CFR 21 Part 812

Answer 1

Investigational Device Exemptions

Question 2

What is a significant risk device? (4)

Answer 2

A device that:
1) is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
2) Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject.
3) is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject
4) Otherwise presented a potential for serious risk to the health safety, or welfare of a subject.

Question 3

What is a transitional device?

Answer 3

a device subject to 520(l) of the act that is a device that FDA considered to be a new drug or antibiotic before MAY 28 1976.

Question 4

What is a device?

Answer 4

A device, other than a transitional device, in commercial distribution immediately after May 28 1976 when used for investigations in accordance with the indications in labeling in effect at that time.

Question 5

Investigational Plan should include:

Answer 5

a) purpose
b) protocol
c) risk analysis
d) description of device
e) monitoring procedures.
f) labeling
g) consent materials
h) IRB information
i) Other institutions
j) additional records and reports.

Question 6

What types of changes would require a supplemental application? (IDE)

Answer 6

1) changes in investigational plan requiring prior approval
2) Changes effected for emergency use
3) Changes effected with notice to FDA within 5 days.
4) Changes submitted in annual report.

Question 7

Can a sponsor make certain changes without prior approval of a supplemental application? If so what is the timeline?

Answer 7

Yes – but the sponsor must notified the FDA within 5 days of the changes going in to effect.

Question 8

What types of changes can the sponsor make w/o prior approval on a supplemental application?

Answer 8

1) Developmental changes, including manufacturing changes that do not constitute a significant change in design or basic operation and are made based on basic information gathered during the investigation.
2) Changes to clinical protocol that do not affect validity of data, scientific soundness, or the rights safety, and welfare of human subject.
3) Definition of credible information
4) Notice of IDE change

Question 9

What are the responsibilities of Sponsors as outlined in 21CFR Part 812?

Answer 9

1) Gaining FDA and IRB approval before beginning the investigation
2) Selecting investigators and monitors
3) Informing investigators
4) monitoring investigations
5) Emergency Research

Question 10

Responsibilities of Investigators as outlined in 21 CFR Part 812

Answer 10

1) Awaiting approval.
2) Compliance.
3) Supervising device use.
4) Financial disclosure.
5) Disposing of device.

Question 11

What does an approved IDE permit?

Answer 11

An approved IDE permits a device to be shipped lawfully for the purposes of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that would apply to devices in commercial distribution.

Question 12

For IDE, when does a sponsor need to report an unexpected adverse device event?

Answer 12

10 working days.

Question 13

For emergency use of a device, where immediate use of the product was required and the patient was not able to be consented, how long does the sponsor have to notify the FDA of the use of the product?

Answer 13

5 working days

Question 14

For an Significant Risk IDE, how long after the date of finishing the clinical trail does a sponsor have to notify the FDA that they finished the clinical trial?

Answer 14

30 working days.

Question 15

For significant risk IDE, how long after finishing the clinical trial does the sponsor have to submit their final report?

Answer 15

Within 6 months of finishing the trial.

Question 16

For non-significant risk IDEs, does the sponsor need to send a final report to FDA? How long after finishing a trial?

Answer 16

No, only to the IRB and within 6 months of finishing the trial.

Question 17

How often does the investigator need to provide an annual report to the sponsor for an IDE?

Answer 17

At least yearly (this is typically the same as the continuing review provided to the IRB).

Question 18

For IDE, when and to who does the investigator have to submit a final report after finishing a clinical trial?

Answer 18

Investigator submits a final report to the Sponsor AND to the IRB within 3 months of finishing the trial.

Question 19

For a significant risk or non-significant risk IDE, how often does a sponsor need to submit an annual report and to who?

Answer 19

For all IDE’s: At least yearly progress reports to IRB.

For SR IDE’s: At least yearly to IRB AND to FDA.

Question 20

What types of devices are considered IDE exempt?

Answer 20

-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 21

What is an Unanticipated adverse device effect?

Answer 21

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 22

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

Answer 22

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

Question 23

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

Answer 23

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 24

What is treatment use of an investigational device?

Answer 24

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 25

What records should the investigator retain during an IDE trial?

Answer 25

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 26

What records should the sponsor retain during an IDE trial?

Answer 26

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 27

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

Answer 27

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

Question 28

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 28

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