entering the us market: medical devices carole c. carey bsee, m.engineering carole.carey@fda.hhs.gov...

Entering the US Market: Medical Devices

Carole C. Carey BSEE, M.Engineeringcarole.carey@fda.hhs.govDirector, International StaffUS Food and Drug AdministrationCenter for Devices and Radiological Health

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Topics Brief FDA Organizational Structure Regulatory Paradigm, Device Classification Two Most Common Pathways to Market Levels of Regulatory Control (General Controls &

Special Controls) Importing into the U.S. CDRH Databases and Resources

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The U.S. Food and Drug Administration is

Scientific, Regulatory, Public Health Agency

Mission is to protect and promote public health.

http://www.fda.gov/

Authority to regulate medical devices Federal FD&C Act

Established regulatory controls for medical devices (May 28, 1976)

21 CFR Parts 800-1299

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Department of Health & Human Services

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FDA Centers and Regulated Products

Food Drugs 　 Medical Devices * Biologics Animal Feed and Drugs Cosmetics Radiation-Emitting

Products * Combination Products

(drug-device*, biologic-device*, drug-biologic) Primary mode of action RFD (Request for

Designation)

CDER Center for Drugs andEvaluation Research

CVMCenter for

Veterinary Medicine

NCTRNational Center

for Toxicological Research

CFSANCenter for Food Safetyand Applied Nutrition

CBER Center for Biologics and

Evaluation Research

CDRHCenter for Devices

and Radiological Health

FDA

*

Office of Regulatory Affairs (ORA)is the lead office for all field activities.

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Center DirectorDr. Daniel Schultz

Office of Device Evaluation ODE Office of Compliance (OC)

Office of Science and Engineering Laboratories (OSEL)

Office of Surveillanceand Biometrics (OSB)

Office of Communication,Education and Radiation Programs (OCER) *International Affairs

Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

http://www.fda.gov/cdrh/index.html

CDRH

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16 Classification Regulations21 CFR (part 800-1299)

Clinical chemistry and clinical toxicology

Hematology and pathology

Immunology and microbiology

Anesthesiology Cardiovascular Dental Ear, nose and throat Gastroenterology &

urology devices

General and plastic surgery

General hospital and personal use

Neurological Ophthalmic Orthopedic and physical

medicine Obstetrical and

gynecological Radiology

Medical Device Definition in Sec 201(h) of the FD&C Act

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Regulatory Paradigm: Balancing Risks and Benefits

Getting Getting safe safe and effective and effective devicesdevices to to market as market as quickly as quickly as possible…possible…

Getting Getting safe safe and effective and effective devicesdevices to to market as market as quickly as quickly as possible…possible…

… … while while ensuring that ensuring that

devices devices currently on currently on the market the market

remain remain safe safe and effectiveand effective..

… … while while ensuring that ensuring that

devices devices currently on currently on the market the market

remain remain safe safe and effectiveand effective..

Helping the public get Helping the public get science-based accurate science-based accurate informationinformation about medical devices and radiological about medical devices and radiological

products needed to improve health.products needed to improve health.

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Risk-based Classification, Level of Reg Control, & Submission Type

510(k) Exempt

Class I Class II Class III

Very low Low (~782) Medium (~799)

High (~119)

General Controls (may or may not be GMP exempt)

General ControlsPremarket Notification or 510(k)

General & Special Controls510(k) submission

General & Special ControlsPremarket Approval

1700 generic type of devices

Level of Risk & Level of Regulatory Control

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Class I / II ExemptionsFD&C Act 513(d)(2A)

Over 800 generic types of Class I devices and 60 Class II devices are exempted from the premarket notification requirement (Federal Register)

510(k) Exempt Devices - approximately 47%Class I 93%Class II 9%

Devices exempt from 510(k) are: “preamendment devices” not significantly changed

or modified; or Class I/II devices specifically exempted by regulation.

http://www.fda.gov/cdrh/devadvice/3133.html

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Examples of Device ClassesMedical Device Classes:

Class I

General Controls

Most exempt from premarket submission

Class II Special ControlsPremarket Notification [510(k)]

Class III

Require Premarket Approval [PMA]

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What are General Controls?

Basic authorities that provide FDA with the means to regulate medical devices.

Applies to all medical devices regardless of classification, are subject to premarket and postmarket regulatory controls.

Establishment registration and device listing

Premarket notification or 510(k), if not exempt

Labeling

Misbranding

Adulteration

Quality Systems

Records and Reports / Medical Device Reporting (MDR)

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What are Special Controls?

Postmarket Surveillance Study

Patient Registries

Guidelines (e.g., Glove Manual)

Mandatory Performance Standard

Recommendations or Other Actions

Special Labeling (e.g., 882.5970, Cranial Orthosis)

General controls alone are insufficient to assure safety and effectiveness of Class II devices

Existing methods are available to provide such assurances.

Special controls may include special labeling requirements, mandatory performance standards and postmarket surveillance.

A few Class II devices are exempt from the premarket notification.

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Two Most Common Pathways to Market in the U.S. Premarket Notification (PMN or 510(K))

Safe and effective to a legally marketed (predicate) device through demonstration of substantial equivalence

Class I, II, or III (pre-amendment)

Premarket Approval (PMA) Demonstration of safety and effectiveness (supported by

clinical data) Class III (new, high risk devices and no predicate device,

new indications)

The primary regulation that allows to conduct clinical trials using unapproved medical devices in the U.S. without complying with the FD&C Act is…

the IDE or Investigational Device Exemption (21 CFR Part 812)

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Use of Consensus Standards & Guidance Documents

CDRH Standards Program http://www.fda.gov/cdrh/stdsprog.html

Guidance Documents http://www.fda.gov/cdrh/guidance.html

They are non-binding but very useful in streamlining the regulatory approval process.

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Legal Import of Medical Devices into the U.S. Market Section 801(a) – (d) of the FD&C Act

Subject to examination by FDA even if the product is authorized for marketing in another country.

Devices must be safe and effective.

Must contain informative and truthful labeling in English.

Imported products are required to meet the same standards as domestic goods.

Establishment Registration

Medical Device Listing Compliant Labeling GMP/Quality Systems Appropriate Marketing

Applications unless exempt 510(k) PMA

Adverse Event Reporting, Records/Complaint Files

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Summary

If a product is labeled, promoted or used in a manner defined in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act, it will be regulated by the FDA as a medical device.

USFDA CDRH’s regulatory paradigm is risk-based classification. The levels of regulatory control are based on the classification. Unless exempt, they require a premarket notification clearance or a premarket approval application.

In entering the U.S. medical device market, First determine if it meets definition of medical device. Then determine how the may FDA classify the device, if known. Finally, gather your information, collect the necessary data, organize

your submission.

Products imported into the U.S. meets the same standards and requirements as domestic goods.

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CDRH manages risk across the “Total Product Life Cycle” applied across Center activities

Enabling Enabling TechnologyTechnology

and Innovationand Innovation

Enabling Enabling TechnologyTechnology

and Innovationand Innovation

Efficient, Efficient, Effective, Effective,

and Predictable and Predictable Product Product

DevelopmentDevelopment

Efficient, Efficient, Effective, Effective,

and Predictable and Predictable Product Product

DevelopmentDevelopment

Ensuring Ensuring the Safety ofthe Safety of Marketed Marketed

Medical DevicesMedical Devices

Ensuring Ensuring the Safety ofthe Safety of Marketed Marketed

Medical DevicesMedical Devices

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CDRH Databaseshttp://www.fda.gov/cdrh/databases.html

Registration and Listing Premarket Approvals (PMA) Premarket Notifications (510(k)) Product Classification FDA-Recognized Consensus Standards MAUDE (Manufacturer and User Facility

Device Experience) MDR (Medical Device Reporting) ’92-’96 and others…

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Division of Small Manufacturers, International and Consumer Assistance (DSMICA)

E-mail: dsmica@cdrh.fda.gov Fax (00)1-240-276-3151 Phone (00)1-240-276-3150

Write to us at:

International Staff, Center for Devices and Radiological Health, HFZ-2201350 Piccard DriveRockville, MD 20850 USA

“Device Advice” (a self-service, interactive Site)http://www.fda.gov/cdrh/devadvice/