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Investigational Device Investigational Device ExemptionExemption (IDE) (IDE) Overview for IRBsOverview for IRBs

Investigational Device Investigational Device ExemptionExemption (IDE) (IDE) Overview for IRBsOverview for IRBs

Marian Serge, RNMarian Serge, RNDivision of Bioresearch MonitoringDivision of Bioresearch Monitoring

Office of ComplianceOffice of ComplianceCenter for Devices and Radiological HealthCenter for Devices and Radiological Health

FDAFDA

Marian Serge, RNMarian Serge, RNDivision of Bioresearch MonitoringDivision of Bioresearch Monitoring

Office of ComplianceOffice of ComplianceCenter for Devices and Radiological HealthCenter for Devices and Radiological Health

FDAFDA

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TopicsTopics

• Provision of IDE regulations• Medical device definition• When is an IDE not needed• When is an IDE required• Significant risk (SR) device• Non-significant risk (NSR) device• Non compliance

• Provision of IDE regulations• Medical device definition• When is an IDE not needed• When is an IDE required• Significant risk (SR) device• Non-significant risk (NSR) device• Non compliance

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Provisions of the IDE Regulation - 21 CFR 812

Provisions of the IDE Regulation - 21 CFR 812

• Submission process of an IDE application to FDA for significant risk device studies

• Process for obtaining IDE for non-significant risk device studies

• Assigns responsibilities: sponsor and clinical investigator– Investigator agreement – Device accountability– Reporting and records– IRB review and informed consent

• Submission process of an IDE application to FDA for significant risk device studies

• Process for obtaining IDE for non-significant risk device studies

• Assigns responsibilities: sponsor and clinical investigator– Investigator agreement – Device accountability– Reporting and records– IRB review and informed consent

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IRBs must know three basic thingsIRBs must know three basic things

1. Does the study involve a device?

2. Does it need an IDE?3. Is the device SR or NSR?

1. Does the study involve a device?

2. Does it need an IDE?3. Is the device SR or NSR?

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Question # 1

What is a device?

Question # 1

What is a device?

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What is a medical device?What is a medical device?

• An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent . . .or component, part, or accessory. . . intended to diagnose a disease or condition or to cure, mitigate, treat, or for prevention of disease or it affects the structure or function of the body…..and does not achieve its primary purpose through chemical action. . . or by being metabolized

• An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent . . .or component, part, or accessory. . . intended to diagnose a disease or condition or to cure, mitigate, treat, or for prevention of disease or it affects the structure or function of the body…..and does not achieve its primary purpose through chemical action. . . or by being metabolized

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Question 2

Does the device study require an Investigational Device

Exemption (IDE)?

Question 2

Does the device study require an Investigational Device

Exemption (IDE)?

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Is an Investigational Device Exemption (IDE)

Needed?

Is an Investigational Device Exemption (IDE)

Needed?• “No”

– Practice of medicine– Basic physiological research– Exempt studies [21 CFR 812.2(c)]

“Yes”– Studies that support research or

marketing applications– Investigation that collect safety and

effectiveness– Studies of new indications

• “No”– Practice of medicine– Basic physiological research– Exempt studies [21 CFR 812.2(c)]

“Yes”– Studies that support research or

marketing applications– Investigation that collect safety and

effectiveness– Studies of new indications

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IDE not neededIDE not needed

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Practice of Medicine(no IDE)

Practice of Medicine(no IDE)

• Physician should

– Be well informed about the product

– Use firm scientific rationale and sound medical evidence

– Maintain records on use and effects

• Not research but check Institutional policy: it may require IRB review and Informed Consent

• Physician should

– Be well informed about the product

– Use firm scientific rationale and sound medical evidence

– Maintain records on use and effects

• Not research but check Institutional policy: it may require IRB review and Informed Consent

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Basic Physiological Research (no IDE)

Basic Physiological Research (no IDE)

• Investigating a physiological principle

• No intent to develop the device for marketing

• Only using the device to address the research question – not safety and effectiveness

• Investigating a physiological principle

• No intent to develop the device for marketing

• Only using the device to address the research question – not safety and effectiveness

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Exempt Studies (exempt from 21 CFR 812)

(no IDE)

Exempt Studies (exempt from 21 CFR 812)

(no IDE)

• Description of exempt devices[21 CFR 812.2(c)]– Approved devices used in accordance with

labeling– Most in vitro diagnostic devices (IVDs)– Consumer preference testing, – testing of a minor modification, – testing of a combination of approved

devices• FDA post approval studies

• Description of exempt devices[21 CFR 812.2(c)]– Approved devices used in accordance with

labeling– Most in vitro diagnostic devices (IVDs)– Consumer preference testing, – testing of a minor modification, – testing of a combination of approved

devices• FDA post approval studies

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IDE requiredIDE required

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Studies that support research or marketing

(IDE required)

Studies that support research or marketing

(IDE required)• Significant risk device research

– Submission of an Investigational Device Exemption (IDE) application to FDA

– Follow all of 21 CFR 812• Non-significant risk device research

– IRB approval; after which the study is considered to have an IDE

– Follow only 21 CFR 812.2(b)

• Significant risk device research– Submission of an Investigational

Device Exemption (IDE) application to FDA

– Follow all of 21 CFR 812• Non-significant risk device research

– IRB approval; after which the study is considered to have an IDE

– Follow only 21 CFR 812.2(b)

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Results of an investigation to FDA

(IDE needed)

Results of an investigation to FDA

(IDE needed)

• Clinical investigations of devices where safety and effectiveness data are collected will require an IDE

• Clinical investigations of devices where safety and effectiveness data are collected will require an IDE

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Studies of new indications (IDE needed)

Studies of new indications (IDE needed)

• New intended use of an approved device– Different age population – New disease or condition– Different body placement– Changing from ‘treatment’ to

‘prevention’ for the same disease• Also, new materials or design used

in approved devices

• New intended use of an approved device– Different age population – New disease or condition– Different body placement– Changing from ‘treatment’ to

‘prevention’ for the same disease• Also, new materials or design used

in approved devices

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Where’s the Line? Where’s the Line?

NO IDE

• Practice of Medicine• Basic physiological

research• Exempt studies• Studying a

cleared/approved device w/in label

NO IDE

• Practice of Medicine• Basic physiological

research• Exempt studies• Studying a

cleared/approved device w/in label

IDE

• Studies of investigational devices (support research or marketing applications)

• Studies of new indications

IDE

• Studies of investigational devices (support research or marketing applications)

• Studies of new indications

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Question 3

Is the device SR or NSR?

Question 3

Is the device SR or NSR?

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Significant Risk DeviceDefinition

Significant Risk DeviceDefinition

• Intended as an implant and– presents a potential serious risk

to the health, safety, or welfare of a subject

Or

• Intended as an implant and– presents a potential serious risk

to the health, safety, or welfare of a subject

Or

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Significant Risk DeviceDefinition

Significant Risk DeviceDefinition

• Is purported or represented to be for a use in supporting or sustaining human life –and presents a potential serious

risk to the health, safety, or welfare of a subject

Or

• Is purported or represented to be for a use in supporting or sustaining human life –and presents a potential serious

risk to the health, safety, or welfare of a subject

Or

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Significant Risk DeviceDefinition

Significant Risk DeviceDefinition

• 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 serious risk

to the health, safety, or welfare of a subject

Or

• 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 serious risk

to the health, safety, or welfare of a subject

Or

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Significant Risk DeviceDefinition

Significant Risk DeviceDefinition

• Otherwise presents a potential for serious risk to the health safety or welfare of the subject

• Examples of SR devices: stents, respirators, dialysis machines, sutures, organ storage units, dental lasers for hard tissue, deep brain stimulators, female condoms, etc

• Otherwise presents a potential for serious risk to the health safety or welfare of the subject

• Examples of SR devices: stents, respirators, dialysis machines, sutures, organ storage units, dental lasers for hard tissue, deep brain stimulators, female condoms, etc

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Significant Risk Device IDEs Significant Risk Device IDEs • Sponsor submits IDE application to FDA• FDA approves or disapproves or• FDA conditionally approves which means

there are no safety concerns and the study can begin while deficiencies are being addressed

• After FDA approval and IRB approval the SR device study can begin

• Sponsor submits IDE application to FDA• FDA approves or disapproves or• FDA conditionally approves which means

there are no safety concerns and the study can begin while deficiencies are being addressed

• After FDA approval and IRB approval the SR device study can begin

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Non-significant risk device

Non-significant risk device

• Any device that is not significant riskExamples:

–caries removal solution–contact lens, daily wear–gastroenterology and urology

endoscopes and/or accessories–externally worn monitors for

insulin reactions

• Any device that is not significant riskExamples:

–caries removal solution–contact lens, daily wear–gastroenterology and urology

endoscopes and/or accessories–externally worn monitors for

insulin reactions

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Non-significant risk device IDEs

Non-significant risk device IDEs

• Sponsor presents the IRB with– protocol & a brief explanation why the device

is not a significant risk device

• IRB also determines whether the device is SR or NSR

• If IRB determination agrees with sponsor’s NSR determination the IRB can review and approve the study using the criterial at 21CFR 56.111

– it is considered to have approved application for IDE

• No formal IDE submission to FDA

• Sponsor presents the IRB with– protocol & a brief explanation why the device

is not a significant risk device

• IRB also determines whether the device is SR or NSR

• If IRB determination agrees with sponsor’s NSR determination the IRB can review and approve the study using the criterial at 21CFR 56.111

– it is considered to have approved application for IDE

• No formal IDE submission to FDA

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Quick summary SR and NSR device studies

Quick summary SR and NSR device studies

• Significant risk device study–Requires FDA and IRB approval

• Non-significant risk device study–Requires IRB approval

• Need help deciding? – CDRH has procedures: see handout.

• Want to see FDA’s decision letter? –Ask the sponsor.

• Significant risk device study–Requires FDA and IRB approval

• Non-significant risk device study–Requires IRB approval

• Need help deciding? – CDRH has procedures: see handout.

• Want to see FDA’s decision letter? –Ask the sponsor.

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IRB Non-complianceIRB Non-compliance

• Inadequate initial or continuing review – Frequency of review– Expedited review– SR determination

• Inadequate records– SOPs– Minutes, including the vote– Membership roster– Study documentation

• Inadequate initial or continuing review – Frequency of review– Expedited review– SR determination

• Inadequate records– SOPs– Minutes, including the vote– Membership roster– Study documentation

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Clinical InvestigatorNon-compliance

Clinical InvestigatorNon-compliance

• Failed to – Follow investigational plan,

investigator agreement, or protocol – Document case history and device

exposure – Obtain adequate informed consent

• Failed to – Follow investigational plan,

investigator agreement, or protocol – Document case history and device

exposure – Obtain adequate informed consent

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Clinical InvestigatorNon-compliance

Clinical InvestigatorNon-compliance

• Failed to– Control of investigational device– Report Unanticipated ADEs– Obtain FDA or IRB approval to

conduct study

• Failed to– Control of investigational device– Report Unanticipated ADEs– Obtain FDA or IRB approval to

conduct study

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SummarySummary

• Medical device definition• Significant risk (SR) device• Non-significant risk (NSR) device• IDE not required• IDE required• IRB and investigator non-

compliance

• Medical device definition• Significant risk (SR) device• Non-significant risk (NSR) device• IDE not required• IDE required• IRB and investigator non-

compliance

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Contact Information and Websites

Contact Information and Websites

• IDE Staff –Sheila.Brown@fda.hhs.gov–Stephen Rhodes, Director

•Websites:– www.fda.gov and click on Medical Devices

– www.fda.gov/oc/ohrt/irbs/

• IDE Staff –Sheila.Brown@fda.hhs.gov–Stephen Rhodes, Director

•Websites:– www.fda.gov and click on Medical Devices

– www.fda.gov/oc/ohrt/irbs/

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Marian Serge, RNDBM, OC, CDRH, FDA

Marian,Serge@FDA.HHS.GOV(301) 796-5644

Marian Serge, RNDBM, OC, CDRH, FDA

Marian,Serge@FDA.HHS.GOV(301) 796-5644