entering the us market: medical devices carole c. carey bsee, m.engineering [email protected]...
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Entering the US Market: Medical Devices
Carole C. Carey BSEE, [email protected], 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
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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: [email protected] 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/