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Entering the US Market: Medical Devices


Entering the US Market: Medical Devices Carole C. Carey BSEE, M.Engineering carole.carey_at_fda.hhs.gov Director, International Staff US Food and Drug Administration – PowerPoint PPT presentation

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Title: Entering the US Market: Medical Devices

Entering the US Market Medical Devices
  • Carole C. Carey BSEE, M.Engineering
  • carole.carey_at_fda.hhs.gov
  • Director, International Staff
  • US Food and Drug Administration
  • Center for Devices and Radiological Health

  • 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

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 FDC Act
  • Established regulatory controls for medical
    devices (May 28, 1976)
  • 21 CFR Parts 800-1299

Department of Health Human Services
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)

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

16 Classification Regulations 21 CFR (part
  • 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
Regulatory Paradigm Balancing Risks and Benefits
while ensuring that devices currently on the
market remain safe and effective.
Getting safe and effective devices to market as
quickly as possible
Helping the public get science-based accurate
information about medical devices and
radiological products needed to improve health.
Risk-based Classification, Level of Reg Control,
Submission Type
1700 generic type of devices
  • Level of Risk Level of Regulatory Control

Class I / II Exemptions FDC 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

Examples of Device Classes
  • Medical Device Classes
  • Class I
  • General Controls
  • Most exempt from premarket submission
  • Class II
  • Special Controls
  • Premarket Notification 510(k)
  • Class III
  • Require Premarket Approval PMA

What are General 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
  • 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.

What are Special Controls?
  • General controls alone are insufficient to assure
    safety and effectiveness of Class II devices
  • Existing methods are available to provide such
  • Special controls may include special labeling
    requirements, mandatory performance standards and
    postmarket surveillance.
  • A few Class II devices are exempt from the
    premarket notification.
  • Postmarket Surveillance Study
  • Patient Registries
  • Guidelines (e.g., Glove Manual)
  • Mandatory Performance Standard
  • Recommendations or Other Actions
  • Special Labeling (e.g., 882.5970, Cranial

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

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.

Legal Import of Medical Devices into the
U.S. Market Section 801(a) (d) of the FDC 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
  • 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

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

CDRH manages risk across the Total Product Life
Cycle applied across Center activities
CDRH Databases http//www.fda.gov/cdrh/databases.h
  • Registration and Listing
  • Premarket Approvals (PMA)
  • Premarket Notifications (510(k))
  • Product Classification
  • FDA-Recognized Consensus Standards
  • MAUDE (Manufacturer and User Facility Device
  • MDR (Medical Device Reporting) 92-96
  • and others

Division of Small Manufacturers, International
and Consumer Assistance (DSMICA)
  • E-mail dsmica_at_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-220
  • 1350 Piccard Drive
  • Rockville, MD 20850 USA

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