Entering the US Market:
Medical Devices
Carole C. Carey BSEE, M.Engineering
carole.carey@fda.hhs.gov
Director, International Staff
US Food and Drug Administration
Center for Devices and Radiological Health
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*, biologicdevice*, drug-biologic)
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Primary mode of action
RFD (Request for
Designation)
*
CDRH
Center for Devices
and Radiological Health
CDER
Center for Drugs and
Evaluation Research
CBER
Center for Biologics and
Evaluation Research
FDA
CVM
Center for
Veterinary Medicine
CFSAN
Center for Food Safety
and Applied Nutrition
NCTR
National Center
for Toxicological Research
Office of Regulatory Affairs (ORA)
is the lead office for all field activities.
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CDRH
Center Director
Dr. Daniel Schultz
Office of Device Evaluation ODE
Office of Compliance (OC)
Office of Science and
Engineering Laboratories (OSEL)
Office of Surveillance
and 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
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16 Classification Regulations
21 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 safe
and effective
devices to
market as
quickly as
possible…
… while
ensuring that
devices
currently on
the market
remain safe
and effective.
Helping the public get science-based accurate
information about medical devices and radiological
products needed to improve health.
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Risk-based Classification, Level of
Reg Control, & Submission Type
1700 generic type of devices
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 Controls
Premarket
Notification or
510(k)
General & Special
Controls
510(k)
submission
General & Special
Controls
Premarket
Approval
Level of Risk & Level of Regulatory Control
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Class I / II Exemptions
FD&C Act 513(d)(2A)
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Over 800 generic types of Class I devices
and 60 Class II devices are exempted from the
premarket notification requirement (Federal Register)
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510(k) Exempt Devices - approximately 47%
Class I
93%
Class II
9%
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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 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]
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What are General Controls?
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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.
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Establishment
registration and device
listing
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Premarket notification or
510(k), if not exempt
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Labeling
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Misbranding
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Adulteration
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Quality Systems
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Records and Reports /
Medical Device Reporting
(MDR)
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What are Special Controls?
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Postmarket Surveillance
Study
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Patient Registries
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Guidelines (e.g., Glove
Manual)
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Mandatory Performance
Standard
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Recommendations or
Other Actions
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Special Labeling (e.g.,
882.5970, Cranial
Orthosis)
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General controls alone are
insufficient to assure safety
and effectiveness of Class II
devices
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Existing methods are
available to provide such
assurances.
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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.
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Premarket Notification (PMN or 510(K))
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Safe and effective to a legally marketed (predicate) device
through demonstration of substantial equivalence
Class I, II, or III (pre-amendment)
Premarket Approval (PMA)
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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
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510(k)
PMA
 Adverse Event Reporting,
Records/Complaint Files
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Summary
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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.
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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.
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In entering the U.S. medical device market,
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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
Efficient,
Effective,
and Predictable
Product
Development
Ensuring
the Safety of
Marketed
Medical Devices
Enabling
Technology
and Innovation
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CDRH Databases
http://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)
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E-mail:
Fax
Phone
dsmica@cdrh.fda.gov
(00)1-240-276-3151
(00)1-240-276-3150
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Write to us at:
International Staff, Center for Devices
and Radiological Health, HFZ-220
1350 Piccard Drive
Rockville, MD 20850 USA
“Device Advice” (a selfservice, interactive Site)
http://www.fda.gov/cdrh/devadvice/
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