21 CFR 812

Question 1

What is 21 CFR part 812

Answer 1

Investigational device exemptions

Question 2

Definition of significant risk device

Answer 2

presents a potential for serious risk to health safety or welfare AND

• intended as an implant
• is purported or represented to be for a use in sustaining or supporting human life
• is for a use of substantial importance in diagnosing curing mitigating or treating disease or otherwise preventing impairment of human health
• otherwise presents a potential for serious risk to health safety or welfare

**check for others

Question 3

Conditions under which a sponsor mush submit an IDE application to FDA

Answer 3

• sponsor intends to use a significant risk device in an investigation
• sponsor intends to conduct an investigation that involves an expedition from informed consent
• the FDA notifies the sponsor that an application is required for an investigation

**check for more

Question 4

Who makes the initial risk determination for an investigational device

Answer 4

Sponsor

Question 5

What must happen before a sponsor may begin an investigation

Question 6

Under what circumstances is a diagnostic device exempt from application regulations under 21 CFR 812

Answer 6

• is non-invasive
• AND does not require an invasive sampling procedure that presents significant risk
• AND Does not by design or intention introduce energy into the subject
• AND is not used as a diagnostic procedure without confirmation of the diagnosis by a medically established product or procedure

Question 7

How long until an investigation involving an investigational device can begin after the FDA receives the application

Answer 7

30 days unless the the FDA notifies the sponsor that the investigation may not begin

Question 8

Can the IRB risk determination differ from the risk determination made by sponsor?

Answer 8

yes

Question 9

An investigator or sponsor shall maintain the records required by 812.40(b)(6) during an investigation for a period of how long after the latter of which two dates?

Answer 9

2 years

• the date on which the investigation is terminated or completed
• the date that the records are no longer required for purposes of supporting a premarket approval application or notice of completion of a product development protocol

Question 10

When can an investigational device be considered to have an approved application for IDE’s

Answer 10

it may be considered approved as long as

• it is NOT a significant risk device
• the FDA has NOT notified a sponsor under 812.20 (a) that approval is required

Question 11

Necessary elements of a protocol

Answer 11

Summary

Inclusion/exclusion

Randomization

Visits/Procedures

Clinical events/endpoints

Adverse Events/Stopping rules

Admendments

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