intro to medical devices

8/3/2019 Intro to Medical Devices

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Presented by Catherine Parker, RNConsumer Safety OfficerDivision of Bioresearch MonitoringOffice of Compliance

Center for Devices and Radiological Health

Medical Devices, Device Regulations,

and Medical Device Trials

Medical Devices, Device Regulations,

and Medical Device Trials


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Objectives

Define medical device

Describe the classifications of devices

Describe the ways a device can get to market

Describe how medical device clinical trials differ

from drug trials


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Medical Devices


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Medical Device Definition An instrument, apparatus, implement, machine, contrivance,

implant, in vitro reagent, or other similar article, including anycomponent, part, or accessory which is:

Recognized in the official National Formulary, or the United

States pharmacopeia, or any supplement to them

Intended for use in the diagnosis of disease or conditions,or in the cure, mitigation, treatment, or prevention ofdisease in man or other animals

Intended to affect the structure or any function of the body of

man or other animals

Which does NOT achieve its primary intended purposesthrough chemical action within or on the body of man or otheranimals and which is NOT dependent upon being metabolizedfor the achievement of its intended purposes.

Definition of DeviceFood Drug and Cosmetic Act 201(h)


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The Important Points

Device definition excludes products that:

Achieve their primary intended purpose

through chemical action within the body

Are dependent upon being metabolized for

the primary achievement of their primary

intended purposes


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Medical Devices are Classified by Risk


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Class I Devices

General controls are

sufficient to provide

reasonable assuranceof the safety and

effectiveness

Examples: elastic

bandages, examinationgloves, and hand-held

surgical instruments


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General ControlsProhibition against adulterated or misbranded devices

Premarket notification 510(k) requirements

Good Manufacturing Practices (GMPs)

Labeling

Registration of manufacturing facilities

Listing of device types

Record keeping

Repair, replacement or refund


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Class II Devices .

General controls aloneare insufficient to assuresafety and effectiveness,and existing methods are

available to provide suchassurances.

Also subject to specialcontrols

Examples: poweredwheelchairs, infusionpumps, and surgicaldrapes


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Special ControlsPerformance standards (discretionary, voluntary nationalor international standard, recognized by rulemaking)

Post-market surveillance

Patient registries

Development and dissemination of guidelines/guidances

Design controls

Recommendations and other appropriate actions

Tracking requirements


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Class III DevicesInsufficient information existsto determine that general andspecial controls are sufficientto provide reasonableassurance of the safety andeffectiveness of such devices

Such devices are:

Life sustaining or lifesupporting

Substantial importance inpreventing impairment ofhuman health; or

Present unreasonable riskof illness or injury


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Getting a Device to Market


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Used for devices that are substantially

equivalent (SE) to a predicate device

Manufacturer must notify FDA 90 days before

proposing to market a device

Burden is on the manufacturer to demonstrate

that the device is SE.

Premarket Notification 510(k)

The device is as safe and effective as an

existing marketed device.

21 C.F.R. 807


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Class III devices

New types of devices

Previously found not SE

May require pre-clinicaland clinical data obtained

from an investigationaldevice exemption (IDE)

Premarket Approval

Application (PMA) 21 C.F.R. 814


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Used for devices that will benefit

patients with rare conditions

(


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Product development protocol (PDP)

An alternative to a PMA whereby the investigation of a

device and the development of information necessary forits approval are merged into one regulatory submission

De Novo classification pathway

A streamlined reclassification process for devices that

are low-risk but not SE. They would automatically beassigned a Class III status. The de novo pathway can geta novel low-risk device reclassified to Class I orII thusavoiding a PMA

Other ways to Market


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Custom Device

It is intended for use byan individual patientnamed in the order form

Made in a specific formfor that patient or

Made to meet the specialneeds of MD or dentist(i.e. tool)

21 C.F.R. 812.3(b)

It is different from devicesavailable

It is not available to, or used byother MDs or dentists

It is not available in finished formfor purchase or dispensing uponprescription

It is not offered for commercialdistribution through labeling oradvertising

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/

UCM127067.pdf


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Medical Device Research


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Research Applications21 C.F.R. 812

Investigational Device Exemption (IDE)

Approved by an IRB and, if applicable, FDA

Informed consent from all subjects

Labeling for investigational use only

Monitoring of the study

Submission of required reports and records

Permits an unapproved device to be shipped lawfully


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Device Clinical Research

Significant risk (SR)

IDE submission

Non-Significant risk (NSR)

Abbreviated requirements

IDE exempt


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SR vs. NSR Determination

Decision based on use of device in study IDEsubmission

Sponsor makes initial assignment

IRB makes determination

FDA can disagree


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Significant Risk Definition

Decision based onuse of device in study

IDE application

Sponsor makesinitial assignment

IRB makesdetermination

FDA can disagree


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NSR Determination

No IDE application to FDA

Considered to have an IDE

Abbreviated requirements only


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Labels device

Obtains IRB approval

SR vs. NSRdetermination

Ensures informedconsent

IRB may waivedocumentation ofconsent if minimal risk

Abbreviated Requirements21 C.F.R. 812.2(b)

Monitors study

Maintains records

Makes reports

Ensure CI maintainsrecords and makes reports

Refrains from promotionand other practices


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In commercial use before May 28, 1976

SE to device in commercial use before May 28, 1976

and used or investigated for labeled indication

In vitro diagnostics (IVDs)

Consumer preference testing

Solely for veterinary or lab animal use

IDE Exempt Device Research21 C.F.R. 812.2(c)


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Access to Unapproved Devices


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Emergency Use

Compassionate Use

Treatment Use

ContinuedAccess

Early/Expanded Access

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc

e/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/uc

m051345.htm


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Life-threatening or seriouscondition with no alternative

Before or during an IDE

FDA approval not required

Report to the IRB within 5days

Report to the Sponsorand/or FDA

Emergency Use

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinic

alTrials/G

uidancesInformationSheetsandNotices/ucm118823

.htm


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Serious condition withno alternative

Before or during an IDEstudy

FDA approval required

Compassionate Use

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc

e/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/uc

m051345.htm#continuedaccess


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Life-threatening or serious disease

No alternative

Controlled clinical trial

Sponsor pursuing marketing approval


Treatment Use21 C.F.R. 812.36


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Public health need or

Preliminary evidence that the device will be effective

with no significant safety concerns

Occurs after the completion of the clinical trial


Continued Access

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance

/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm

051345.htm#continuedaccess


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Trials


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Regulatory Similarities in Trials

FDA approval required before test articles can be

shipped

IDE orIND

FDA regulations specify sponsor and clinical

investigator responsibilities:

21 CFR 812 and CFR 312


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Regulatory Differences in Trials

Devices: Investigator agreement generated by

the sponsor per 21 CFR 812.43(c)

Drugs: Statement ofInvestigator - Form 1572


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Regulatory Differences in Trials

Contract Research Organizations (CRO)

Device regulations are silent about them

Drug regulations define transfer of obligations to

CRO


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Adverse Event Differences in Trials

Drugs

CI report any adverseeffects that mayreasonably be regardedas caused by, or probablycaused by, the drug.

Sponsors notify FDA ofany unexpected fatal orlife-threatening eventwithin 7 calendar days

Devices

CI report anyunanticipated adversedevice effects (UADE)

Sponsors report resultsof an evaluation of aUADE to FDA and allreviewing IRBs within 10working days

21 C.F.R. 812.150(a)(1) 21 C.F.R.312.32


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Medical Device Trials

Subject population usually in the 100s rather than 1000s

No phases: Feasibility then pivotal study

Blinding is less common

Controls vary

No placebo rather sham, active, historical

CI training often critical (e.g. Human Factors)

IRBs play a critical role


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Summary


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Other References

CDRH Homepage

www.fda.gov/cdrh

CDRH Learnhttp://www.fda.gov/Training/CDRHLearn/

ucm162015.htm

Device Advice

www.fda.gov/cdrh/devadvice

Computerized Systems

http://www.fda.gov/downloads/Drugs/Gui

danceComplianceRegulatoryInformation/Guidances/UCM070266.pdf


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Device Contacts for Questions

Questions related to compliance:

Cathy Parker, Office ofCompliance, Division of

Bioresearch Monitoring, 301-796-5553

Questions pertaining to SR/NSR:

Office of Device Evaluation

Program Operation Staff 240-276-4040

IRB or Human Subject Protections Marian

Serge, 301-796-5644

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