21 CFR Part 812

Question 1

What is the Title of 21 CFR Part 812, and what is its purpose?

Answer 1

Investigational device exemptions (IDE)

regulatory requirements for IDEs to ensure the safety and effectiveness of medical devices in clinical trials.

Question 2

What parties need to be compliant to 21 CFR Part 812?

Answer 2

Sponsors, investigators, and IRB/IECs are collectively responsible for compliance

Question 3

What is the role of the sponsor in the context of 21 CFR Part 812?

Answer 3

Responsible for submitting the IDE application, ensuring proper monitoring, reporting adverse events, and maintaining regulatory compliance.

Question 4

What should an IDE application contain? and who should it be submitted to?

Answer 4

Sponsor must submit an application containing information on the device, protocol, investigator, monitoring procedures, and consent forms to the FDA.

Question 5

What are the criteria for FDA approval of an IDE application?

Answer 5

The FDA approves an IDE if it determines that the investigation is scientifically sound, will be conducted ethically, and the benefits outweigh the risks.

Question 6

Examples of significant risk devices and non significant risk devices:

What is the main difference in regards to regulations of 21 CFR Part 812?

Answer 6

-Devices intended to sustain or support life, LVAD or valves
-Devices used in diagnostic procedures where the risk is minimal.

-IDE is NOT required to be sent to FDA for NSR devices. NSR needs to be approved by IRB.

Question 7

What is “Premarket approval (PMA)” in the context of 21 CFR Part 812?

Answer 7

This is a stage where FDA evaluates the safety and effectiveness of a device prior to market, utilizing the data from IDE studies to substantiate its decision.

Question 8

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

Answer 8

Investigators are responsible for ensuring the study is conducted in accordance with the investigational plan, protecting subjects, obtaining informed consent, and reporting adverse events.

Question 9

Prohibitive practices of IDE: (4)

Answer 9

1) Promoting or test market of IDE prior to FDA approval for commercial distribution
2) Commercialize it to be sold with a price to compensate for costs
3) Unduly prolonged investigations
4) Claim that an IDE is safe or effective

Question 10

Explicate further on unduly prolonged investigations in the context of 21 CFR 812:

Answer 10

For class II, the results show that this device does not compete with the performance of alternative therapies.

For class III, results cannot justify premarket approval.

Either criteria is met, sponsor will need to terminate the study.

Question 11

Provide 5 possible informational labels of an IDE:

Answer 11

1) name and place of manufacturer
2) Quantity of contents
3) Contraindications
4) Adverse, expected effects
5) Interfering substances/devices

Question 12

What 4 criteria would a device qualify as significant risk?

Answer 12

1) intended as implant and presents serious risk to subject’s health and welfare.
2) Used to sustain human life
3) Used for substantial importance in diagnosing, curing, mitigating, or treating a disease
4) All other devices that could result in potential serious risk of a subject’s safety.

Question 13

T/F: IDE investigations can begin without FDA approval:

Answer 13

F

Question 14

How many copies of IDE applications should be submitted to FDA?

Answer 14

3 copies.
Furthermore, a separate application is needed if the IDE would have exceptions from ICF.

Question 15

List 3 central features of an IDE application:

Answer 15

1) Name/addresses of sponsor with complete report of prior investigations
2) Review of methods and handling of device
3) “Investigator agreements” examples for the study, including sites who have already signed.

Question 16

Investigational plan should be in the following order: (10)

Answer 16

-Purpose
-Protocol
-Risk analysis
-Description of device
-Monitoring procedures
-Labeling
-Consent materials
-IRB information
-Other institutions
-Additional records

Question 17

Why is a report of prior investigations needed?

Answer 17

Prior clinical, animal, and lab testing of a device should be comprehensive as it is the source of justification for proposed investigation.

Question 18

5 stages of responsibilities for investigators during the course of a study:

Answer 18

1. Awaiting approval
   2 Compliance
2. Supervising device use under PI discretion
3. Financial disclosure
4. Disposing of device

Question 19

Can sites recruit patients prior to FDA approval?

Answer 19

No, but they can identify potential patients. Recruitment cannot be conducted until approval.

Question 20

Can FDA inspect patient records that could deidentify subjects?

Answer 20

Yes. This is to give FDA a chance to inquire on reports submitted by investigator to sponsor or IRB where it may have inaccurate or incomplete data.

Question 21

Is form 1572 required for IDE studies?

Answer 21

No. Form 1572: Statement of Investigator is REQUIRED for IND studies. IDE studies need Investigator agreements.

Question 22

Do Class 1 require FDA approval? List examples.

Answer 22

No, but it needs to be listed and registered. Toothbrushes, pads.

Question 23

What does Class 2 devices require?

Answer 23

-It requires FDA clearance, with most requiring premarket notification to FDA.

-Moderate risk devices like surgical gloves and ultrasounds. Needs to meet performance standards.

Question 24

What does Class III devices require?

Answer 24

It needs FDA approval (PMA) as it involves high risk life supporting devices like implants and pacemakers.

Question 25

In an emergency, can a deviation from the investigational plan to protect a subject’s life or physical well-being be made without prior FDA approval?

Answer 25

Yes, However, the sponsor must report the change to the FDA within 5 working days after learning about the deviation. This ensures urgent actions can be taken to protect participants while still keeping the FDA informed.

Question 26

IF an IRB determines that a medical device investigation involves a significant risk (SR) device what happens?

Answer 26

IRB must notify investigator and sponsor. Sponsor cannot start the study unless they follow the guidelines in 812.3 which typically require FDA approval before proceeding the study.

Question 27

Exemption from IDE requirements

Answer 27

Devices that are already legally marketed in the U.S, when used according to their approved labeling

-Devices undergoing diagnostic testing