Medical DevicesMedical DevicesIRB DeterminationIRB Determination

IRB Member Continuing IRB Member Continuing EducationEducation

AAHRRP Element II.2. D.AAHRRP Element II.2. D. Element II.2.D. The IRB or Ethics Element II.2.D. The IRB or Ethics

Committee has and follows written policies Committee has and follows written policies and procedures to conduct reviews by the and procedures to conduct reviews by the convened IRB or Ethics Committee.convened IRB or Ethics Committee.

1.1. Element II.2.D.1. – Initial review Element II.2.D.1. – Initial review 2.2. Element II.2.D.2. – Continuing review Element II.2.D.2. – Continuing review 3.3. Element II.2.D.3. – Review of proposed Element II.2.D.3. – Review of proposed

modifications to previously approved modifications to previously approved researchresearch

HRPP 2.5HRPP 2.5 Convened Meetings of the IRB Convened Meetings of the IRB

The rationale for significant The rationale for significant risk/non-significant risk device risk/non-significant risk device determinations;determinations; or the device is or the device is exempt from the IDE regulations.exempt from the IDE regulations.

Three Basic ThingsThree Basic Things

1.1. Does the study involve a device?Does the study involve a device?

2.2. Is the devise SR or NSR?Is the devise SR or NSR?

3.3. Does the study need and IDE? Does the study need and IDE?

Definition of Medical Definition of Medical Device Device

An instrument, apparatus, implement, An instrument, apparatus, implement, machine, contrivance, implant, in vitro machine, contrivance, implant, in vitro reagent…a component, part o, or reagent…a component, part o, or accessory….intended for a diagnosis of accessory….intended for a diagnosis of disease or condition or cure, mitigation, disease or condition or cure, mitigation, treatment, or prevention of disease or treatment, or prevention of disease or affects the structure or function of the affects the structure or function of the body…and does not achieve primary body…and does not achieve primary purpose through chemical action…or being purpose through chemical action…or being metabolized.metabolized.

Significant Risk DeviceSignificant Risk Device

Presents a potential for serious Presents a potential for serious risk to the health, safety or welfare risk to the health, safety or welfare of a subject. SR devices my include of a subject. SR devices my include implants, devices that support or implants, devices that support or sustain human life, and devices sustain human life, and devices that are substantially important in that are substantially important in diagnosing, curing, mitigating or diagnosing, curing, mitigating or treating disease or in preventing treating disease or in preventing impairment to human health.impairment to human health.

How to Obtain IDE for a How to Obtain IDE for a Study Using a Significant Study Using a Significant

Risk DeviceRisk Device Sponsor submits IDE application to Sponsor submits IDE application to

FDAFDA FDA approves or disapprovesFDA approves or disapproves After FDA approval and IRB After FDA approval and IRB

approval the study can beginapproval the study can begin

Non-Significant Risk (NSR) Non-Significant Risk (NSR) DeviceDevice

A device that is no significant risk.A device that is no significant risk.Examples: externally worn monitors for Examples: externally worn monitors for

insulin reactions, gastroenterology and insulin reactions, gastroenterology and urology endoscopes and/or accessories, urology endoscopes and/or accessories, etc.etc.

IDE for a Study Using Non-IDE for a Study Using Non-Significant Risk DeviceSignificant Risk Device

Sponsor presents the IRB with protocol Sponsor presents the IRB with protocol and a brief explanation why the device and a brief explanation why the device is not a significant risk device. And, any is not a significant risk device. And, any other information requested by the IRB.other information requested by the IRB.

If the IRB determines the device is NSR If the IRB determines the device is NSR and approves the study – the study is and approves the study – the study is considered to have and approved considered to have and approved application for IDEapplication for IDE

No formal IDE submission to FDANo formal IDE submission to FDA

NSR Device StudiesNSR Device StudiesIRB ResponsibilitiesIRB Responsibilities

Review definitionsReview definitions Review Sponsor’s brief explanation Review Sponsor’s brief explanation

of why the devices is NSR and not of why the devices is NSR and not SRSR

Conduct literature searchConduct literature search Search InternetSearch Internet Ask FDA for assistanceAsk FDA for assistance

Making the Risk Making the Risk DeterminationDetermination

What is the basis for the risk?What is the basis for the risk? Proposed use of deviceProposed use of device

What is the nature of harm that may result from What is the nature of harm that may result from the use of the devicethe use of the device

Any additional proceduresAny additional procedures Potential harm from proceduresPotential harm from procedures

Consider how the device is used in the study and Consider how the device is used in the study and not the device alone.not the device alone.

Exempt Studies (exempt from 21 Exempt Studies (exempt from 21 CFR 812)CFR 812)

No IDE Needed No IDE Needed Description of exempt devices [(21 CFR Description of exempt devices [(21 CFR

812.2(c)]812.2(c)]-approved devices used in accordance with -approved devices used in accordance with

labelinglabeling

-most in vitro diagnostic devices (IVDs)-most in vitro diagnostic devices (IVDs)

-consumer preference testing-consumer preference testing

-testing of minor modification-testing of minor modification

-testing of a combination of approved devices-testing of a combination of approved devices

FDA post approval studiesFDA post approval studies

IRB ResponsibilitiesIRB Responsibilities

IRB’s should make the SR or NSR IRB’s should make the SR or NSR determination at a convened determination at a convened meeting.meeting.

IRB should document its SR/NSR IRB should document its SR/NSR determination in the IRB meeting determination in the IRB meeting minutes.minutes.

Maintain all other documentation.Maintain all other documentation.