Transcript Overview Intl MD Reg Landscape

How does the U.S. FDA
Regulate Medical Devices?
Carole C. Carey
Director
CDRH International Staff
U.S. FDA Center for Devices and
Radiological Health
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sep 29 Edmonton, Oct 1 Vancouver
Learning Objectives
To have an awareness and basic
understanding of the FDA’s legal authority,
regulatory framework, principles, and
approach in the management and
supervision of medical devices & radiationemitting devices marketed in the U.S.
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10
2
Outline
Who are we?
What, who and why do we regulate?
How do we do it?
What we do
– Premarket
– Postmarket
– Enforcement
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10
3
Department of Health & Human
Services
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10
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U.S. Food and Drug Administration
Scientific
Regulatory
Public Health Agency
that oversees items accounting for 25 cents
of every dollar spent by consumers.
Protect and Promote Public Health.
http://www.fda.gov/
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10
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U.S. FDA Centers
and Regulated Products
Center for Food Safety &
Nutrition (CFSAN)
Center for Devices &
Radiological Health
(CDRH)
– Food and Cosmetics
Center for Drugs & Evaluation
Research (CDER)
– Drugs
Center for Biologics &
Biologics Research (CBER)
– Biologics, Vaccines
Center for Veterinary Medicine
(CVM)
– Medical devices
– Radiation- emitting
products
– Combination Products
are (drug-device* biologicdevice* drug-biologic)
NEWLY Established!!
FDA Center for Tobacco
Products
– Animal Feed and Drugs
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10
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Acting Center Director
Dr. J. Shuren
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)
Office of In Vitro Diagnostic
Device Evaluation and Safety (OIVD)
Division of Small Manufacturers,
International, and
Consumer Assistance [email protected]
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10
7
U.S. Medical Device Industry
According to the US Census Bureau, there are over 12,000 medical device
manufacturing firms in the US.*
1,405
11%
454
4%
344
3%
Employees Per Firm*
<10
10-19
20-99
100-499
500+
1,334
11%
Smallest
Firms
8,829
71%
* Source: Census Bureau, Number of Firms, Number of Establishments, Employment, and Annual Payroll by
Employment Size of the Enterprise for the United States, All Industries 2005 using NAICS codes 339111,339112,
339113, 339114, 339115, 339116, 334517, 334510, 325413 http://www.census.gov/csd/susb/susb05.htm
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10
8
FDA CDRH Regulates All
Medical Devices in the U.S.
“CDRH protects American
citizens go about their daily
lives with safety measures in
place so that medical devices
and radiological products are
reasonably safe and effective
as intended.”
U.S. Food and Drug Administration
Medical devices
Pacemakers, Contact
Lenses, Hearing Aids...
In-vitro diagnostic
devices (lab tests and
home use tests)
Radiation-Emitting
Products Lasers,
Microwaves...
Combination Products
Drug eluting stents…
Center for Devices and Radiological Health
2009 Sept 8-10
9
Legal Framework: FDA’s Authority
Federal Food Drug and Cosmetic
Act (FDCA)
Medical Device Amendments
(MDA) Act ***May 28,
1976***
Radiation Control for Health
and Safety Act of 1968
– Authority to protect
unnecessary human
exposure to radiation from
medical and non-medical
products in the home,
industry.
U.S. Food and Drug Administration
The Code of Federal Regulations
(CFR)
Title 21 Code of Federal
Regulations
Parts 800 – 1299
medical devices
Title 21 of the Code of
Federal Regulations
Parts 1000 – 1050
electronic product radiation
Center for Devices and Radiological Health
2009 Sept 8-10 10
Regulatory Approach
1. Base degree of control on risk
2. Weigh probable benefit vs. risk to determine
safety and effectiveness
3. Use valid scientific evidence
4. Consider least burdensome means
5. Provide “reasonable assurance”
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10
11
1. Three Tier Classification Scheme
“Medical devices are classified into 3 classes and
regulated according to their complexity and
degree of risk to the public health.”
1976 Medical Device Amendments Act
Two pathways to market
– Show as safe and as effective as device on the market on
May 28, 1976; (510k) or premarket notification.
– Prove device is safe and effective; (PMA) or premarket
approval
Good manufacturing Practices
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 12
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]
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 13
Sixteen Device Specialty Categories
21 CFR (part 800-1299)
Medical Device Definition in Sec 201(h) of the FD&C Act
862 Clinical chemistry and
clinical toxicology
864 Hematology and
pathology
866 Immunology and
microbiology
868 Anesthesiology
870 Cardiovascular
872 Dental
874 Ear, nose and throat
876 Gastroenterology &
urology devices
U.S. Food and Drug Administration
878 General and plastic
surgery
880 General hospital and
personal use
882 Neurological
884 Obstetrical and
gynecological
886 Ophthalmic
888 Orthopedic
890 Physical medicine
892 Radiology 895 Banned
devices
Center for Devices and Radiological Health
2009 Sept 8-10 14
Class I / II Exemptions
FD&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
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm
Devices exempt from 510(k) are:
– “preamendment devices” not significantly changed or
modified; or
– Class I/II devices specifically exempted by regulation.
510(k) Exempt Devices - approximately 47%
Class I - 93% (stethoscope, spectacle lens/frame)
Class II - 9% (radiologic table, dental noble metal alloy)
Not all Exempt devices are exempt from GMP
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 15
What are General Controls?
(Class I, II, III devices)
Basic authorities that
provide FDA with the
means to regulate medical
devices.
Applies to all medical
devices regardless of
classification; all subject
to premarket and
postmarket regulatory
controls.
U.S. Food and Drug Administration
– Premarket notification or
510(k), if not exempt
– Register and List
– Labeling requirements
Prohibit Misbranding
– Prohibit Adulteration
– Quality Systems /GMP
– Records and Reports / (MDR)
Report device failures
Corrective action plans
Center for Devices and Radiological Health
2009 Sept 8-10 16
What are Special Controls?
(Class II devices)
Patient Registries
General controls alone are
insufficient to assure safety and
effectiveness of Class II
devices
Guidelines (e.g., Glove
Manual)
Existing methods are available
to provide such assurances.
Postmarket Surveillance
Study
Mandatory Performance
Standard
Recommendations or
Other Actions
Special controls may include
special labeling requirements,
mandatory performance
standards, tracking and
postmarket surveillance.
Special Labeling (e.g.,
882.5970, Cranial Orthosis)
A few Class II devices are exempt
from the premarket notification.
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 17
Class III Premarket Approval
A demonstration of safety and effectiveness supported
by component level tests, bench tests, clinical data (may
include animal study)
 IDE (investigational device exemption) allows study of
unapproved devices
New, high-risk devices, may have new indications,
predicate device does not apply
Labeling, Instructions for Use, Training requirements
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 18
Risk-based Classification
Level of Regulatory Control
1700 generic type of devices
510(k) Exempt
Class I
Class II
Class III *
Very low
Low (~782)
Medium (~799)
High (~119)
General &
Special Controls
510(k)
submission
General &
Special Controls
Premarket
Approval (PMA)
General Controls General Controls
(may or may not Premarket
be GMP exempt) Notification or
510(k)
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 19
2. Balancing Risks and Benefits
Getting safe
and effective
devices to
market as
quickly as
possible…
… while
keeping
unsafe and
ineffective
devices out of
the market.
Helping the public get science-based accurate
information about medical devices and radiological
products needed to improve health.
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 20
CDRH Health Milestones
“practicing risk-based”
1990 SMDA (Safe
Medical Devices Act)
1997 FDAMA ( FDA
Modernization Act)
– Required user facilities
(hospitals) to report
adverse events
– Allows exemption of Class I
devices
– “Third party” review
– Mandated postmarket
surveillance for certain
devices
– Risk-based approach to
postmarket surveillance
– FDA may order a recall
– Established humanitarian
device exemption process
U.S. Food and Drug Administration
– MedSun Program (a
network of reporting
facilities)
– Quality System Regulation
effective
Center for Devices and Radiological Health
2009 Sept 8-10 21
Reclassification, another
example of risk-based approach
As experience and knowledge about a device increase,
FDA may calibrate the original classification and
readjust based on FDA’s receipt of new information.
May be an “up” classification or a “down” classification
If reclassified to a lower class, must convince the FDA
that less stringent class requirements will be sufficient to
provide reasonable assurance of safety and effectiveness.
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 22
Example of “Down” Classification
Arrhythmia detectors and alarms were
originally classified as Class III devices
Down classified to Class II with special controls
sufficient to mitigate risks to patients.
“Guidance for Industry and FDA Staff - Class II Special
Controls Guidance Document: Arrhythmia Detector and
Alarm” (October 28, 2003)
It is important to describe what is to be
reclassified.
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 23
3. Use valid scientific evidence
Effectiveness is to be determined by:
Well-controlled investigations
One or more clinical investigations where appropriate
[§513(a)(3)]
21 CFR 860.7
Well documented case histories by qualified experts
Other valid scientific evidence, if acceptable (e.g., reports of
significant human experience, non-clinical data, etc.).

Does NOT include
– Isolated case reports
– Random experience
– Reports lacking sufficient details
– Unsubstantiated opinions
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 24
4. Consider Least Burdensome Means
“Least Burdensome” concept, FDAMA 1997
– help to expedite the availability of new device technologies
without compromising scientific integrity in the decision-making
process or FDA’s ability to protect the public health.
Guidance
The Least Burdensome Provisions of the FDA Modernization Act
of 1997: Concept and Principles; Final Guidance for FDA and
Industry
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Guidan
ceDocuments/ucm085994.htm
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 25
5. Provide “reasonable assurance”
“No regulatory mechanism can guarantee that a product
will never cause injury, or will always produce effective
results. Rather, the objective of the legislation is . . .
reasonable assurance that medical devices are safe and
effective.”
-- Report by the House Committee on Interstate
and Foreign Commerce, to accompany the
Medical Device Amendments of 1976
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 26
“Total Product Life Cycle” Vision
applied across Center activities
Efficient,
Effective,
and Predictable
Product
Development
Ensuring
the Safety of
Marketed
Medical Devices
U.S. Food and Drug Administration
Enabling
Technology
and Innovation
Center for Devices and Radiological Health
2009 Sept 8-10 27
Postmarketing Requirements
Quality System/GMP
Adverse Event Reporting
Postmarket surveillance
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 28
Quality System (QS)
Regulation (21 CFR Part 820)
Quality Assurance System covering the design
and manufacture of medical devices sold in
the U.S.
Similar to ISO 13485
Standard for audit of device establishment
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 29
Medical Device Reporting (MDR)
“Adverse Event Reporting”
(21 CFR Part 803)
Mechanism for FDA to identify and monitor
significant adverse events involving medical
devices
Events:
Death, Serious Injury and Malfunction
Reported by: Manufacturer, User Facility, and
Importers of medical devices
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 30
Postmarket Surveillance
Postapproval Studies for various permanent
implants after approval to monitor unexpected
problems
Device Tracking - system for locating
permanent implants/life-sustaining devices
after they leave the hospital
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 31
Enforcement and the Office
of Compliance
Protect the public health by ensuring
that device and radiological health
products are safe and effective by:
Ensuring compliance with applicable laws
and regulations
Enforcement, when needed
Mitigating risks to the public health
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 32
A CT scan is a special X-ray procedure,
where a computer collects the information from
the X-rays and produces images or pictures
of cross-sections through the head or the body.
Regulatory Requirements for
Radiation-Emitting Devices
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sep 29 Edmonton, Oct 1 Vancouver
Medical and Non-Medical
Products
Sunlamps
Ultrasound therapy
Laser therapy and
surgical devices
Radiation therapy
Microwave or ultrasound
diathermy devices
Microwave blood
warmers or sterilizers
Ultraviolet dental curing
devices
U.S. Food and Drug Administration
Televisions receivers and
monitors (cathode ray
tubes only)
X-ray security systems
Microwave ovens
Laser products ( CD
players, light shows,
welding lasers)
Metal halide lighting
Cordless and cellular
telephones
Industrial RF sealers of
plastics and laminates
Center for Devices and Radiological Health
2009 Sept 8-10 34
CT System as a medical device
Class II device (General & Special Controls)
Submit Premarket notification or 510k
– Meet device safety & effectiveness requirements “substantially
equivalent” in characteristics, performance and safety
Manufacturer establishment registration & Device listing
Good manufacturing practices/(QS) regulations
Labeling
– Continue to be cleared for marketing for general imaging
purposes
– A new indication such as CT scanning for whole-body screening
for individuals without symptoms will require a PMA
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 35
CT system as a
radiation-emitting device
Comply with minimum
radiation safety
requirements of the
performance standard
(including labeling) for
– diagnostic x-ray systems
– CT equipment
Manufacturers must
provide certification
meeting the standards.
– Certification is not an FDA
approval!
U.S. Food and Drug Administration
21 CFR PART 1020
Performance Standards for
ionizing radiation
§ 1020.10 - Television
receivers.
§ 1020.20 - Cold-cathode gas
discharge tubes.
§ 1020.30 - Diagnostic x-ray
systems and their major
components.
§ 1020.31 - Radiographic
equipment.
§ 1020.32 - Fluoroscopic
equipment.
§ 1020.33 - Computed
tomography (CT)
equipment.
§ 1020.40 - Cabinet x-ray
systems.
Center for Devices and Radiological Health
2009 Sept 8-10 36
Regulations under the laws
control the requirements
The responsibility for the safety regulation of
radiation-emitting electronic products is shared.
FDA regulates the level of controls and requirements on
the manufacture of the CT systems.
The use of CT systems for medical purposes is
controlled, in the U.S. largely at the state & local
government level.
Practice of medicine
License of the medical practitioners
License or register facilities operating x-ray system
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 37
Reporting Requirements
Applies to products listed in Table 1 of 21CFR, 1002.1
21 CFR 1002.10, 11, 12 Product Reports (Initial,
Supplemental, Abbreviated)
– Documents information on manner of conformity to
standards, labeling, test instrumentation, test
procedures, quality control,
– Must be submitted at least one month before actual
shipment to commerce.
21 CFR 1002.13 Annual Reports
– Documents annual production, results of testing, and
user safety concerns
In our case example, a CT system will require an Initial,
Supplemental and Annual Reports
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 38
2007 FDA Amendments Act
Medical Device Provisions
2007 Amendments, Medical Device User Fee
Electronic Registration and Listing System
Requires Establishment of Unique Device Identification
(UDI) system
Streamlines Inspection by Accredited Persons
Promotes Development of Pediatric Devices
FDAAA sunsets on October 01, 2012
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 39
To summarize, in the U.S. all
medical devices are regulated by FDA
A risk-based regulatory paradigm is used to
establish reasonable assurance of safety and
effectiveness.
The law gives us the flexibility to balance out our
regulatory way of thinking to the level of potential
risk posed by
new products,
new technology,
inspections,
postmarket surveillance, etc.
U.S. Food and Drug Administration
Center for Devices and Radiological Health
2009 Sept 8-10 40
In Recent News….
FDA to Review Medical Devices Marketed
Prior to 1976 Action Addresses GAO
Recommendation, April 9, 2009
U.S. Food and Drug Administration
FDA Proposes Mandatory Electronic
Safety Reporting
New Rules will Help Strengthen
Postmarket Safety Data Collection,
August 20, 2009
Center for Devices and Radiological Health
2009 Sept 8-10 41
Thank you!
Contact Information
Carole C. Carey
Director, CDRH International Staff
FDA Federal Research Center
at White Oak, WO 66, R-4618
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
U.S.A
U.S. Food and Drug Administration
Direct: 1- 301-796-5708
Fax : 1- 301-847-8149
[email protected]
Center for Devices and Radiological Health
2009 Sept 8-10 42