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How does the U.S. FDA Regulate Medical Devices?


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Title: How does the U.S. FDA Regulate Medical Devices?

How does the U.S. FDA Regulate Medical Devices?
  • Carole C. Carey
  • Director
  • CDRH International Staff
  • U.S. FDA Center for Devices and Radiological

Learning Objectives
  • To have an awareness and basic understanding of
    the FDAs legal authority, regulatory framework,
    principles, and approach in the management and
    supervision of medical devices
    radiation-emitting devices marketed in the U.S.

  • Who are we?
  • What, who and why do we regulate?
  • How do we do it?
  • What we do
  • Premarket
  • Postmarket
  • Enforcement

Department of Health Human Services
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//

U.S. FDA Centers and Regulated Products
  • Center for Food Safety Nutrition (CFSAN)
  • Food and Cosmetics
  • Center for Drugs Evaluation Research (CDER)
  • Drugs
  • Center for Biologics Biologics Research (CBER)
  • Biologics, Vaccines
  • Center for Veterinary Medicine (CVM)
  • Animal Feed and Drugs
  • Center for Devices Radiological Health (CDRH)
  • Medical devices
  • Radiation- emitting products
  • Combination Products are (drug-device
    biologic-device drug-biologic)
  • NEWLY Established!! FDA Center for Tobacco


Division of Small Manufacturers, International,
and Consumer Assistance
U.S. Medical Device Industry
According to the US Census Bureau, there are over
12,000 medical device manufacturing firms in the
Employees Per Firm
Smallest Firms
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.g
FDA CDRH Regulates All Medical Devices in the
  • 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.
  • 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

Legal Framework FDAs Authority
  • Federal Food Drug and Cosmetic Act (FDCA)
  • Medical Device Amendments (MDA) Act May 28,
  • Radiation Control for Health and Safety Act of
  • Authority to protect unnecessary human exposure
    to radiation from medical and non-medical
    products in the home, industry.
  • The Code of Federal Regulations (CFR)
  • Title 21 Code of Federal Regulations Parts 800
    1299 medical devices
  • Title 21 of the Code of Federal RegulationsParts
    1000 1050 electronic product radiation

Regulatory Approach
  • Base degree of control on risk
  • Weigh probable benefit vs. risk to determine
    safety and effectiveness
  • Use valid scientific evidence
  • Consider least burdensome means
  • Provide reasonable assurance

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
  • Prove device is safe and effective (PMA) or
    premarket approval
  • Good manufacturing Practices

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

Sixteen Device Specialty Categories21 CFR (part
Medical Device Definition in Sec 201(h) of the
  • 862 Clinical chemistry and clinical
  • 864 Hematology and pathology
  • 866 Immunology and microbiology
  • 868 Anesthesiology
  • 870 Cardiovascular
  • 872 Dental
  • 874 Ear, nose and throat
  • 876 Gastroenterology urology devices
  • 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
Class I / II ExemptionsFDC 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.f
  • Devices exempt from 510(k) are
  • preamendment devices not significantly changed
    or modified or
  • Class I/II devices specifically exempted by
  • 510(k) Exempt Devices - approximately 47
  • Class I - 93 (stethoscope, spectacle
  • Class II - 9 (radiologic table, dental noble
    metal alloy)
  • Not all Exempt devices are exempt from GMP

What are General Controls?(Class I, II, III
  • 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
  • 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.

What are Special Controls?(Class II devices)
  • 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,
    tracking 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

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

Risk-based ClassificationLevel of Regulatory
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 (PMA)
2. Balancing Risks and Benefits
while keeping unsafe and ineffective devices
out of the market.
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.
CDRH Health Milestonespracticing risk-based
  • 1990 SMDA (Safe Medical Devices Act)
  • Required user facilities (hospitals) to report
    adverse events
  • Mandated postmarket surveillance for certain
  • FDA may order a recall
  • Established humanitarian device exemption process
  • 1997 FDAMA ( FDA Modernization Act)
  • Allows exemption of Class I devices
  • Third party review
  • Risk-based approach to postmarket surveillance
  • MedSun Program (a network of reporting
  • Quality System Regulation effective

Reclassification, another example of risk-based
  • As experience and knowledge about a device
    increase, FDA may calibrate the original
    classification and readjust based on FDAs
    receipt of new information.
  • May be an up classification or a down
  • 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.

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

3. Use valid scientific evidence
  • Effectiveness is to be determined by
  • Well-controlled investigationsOne or more
    clinical investigations where appropriate
  • Well documented case histories by qualified
  • 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

513(a)(3) 21 CFR 860.7
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 FDAs
    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//

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

Total Product Life Cycle Vision applied across
Center activities
Postmarketing Requirements
  • Quality System/GMP
  • Adverse Event Reporting
  • Postmarket surveillance

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

Medical Device Reporting (MDR)Adverse Event
Reporting(21 CFR Part 803)
  • Mechanism for FDA to identify and monitor
    significant adverse events involving medical

Events Death, Serious Injury and
Malfunction Reported by Manufacturer, User
Facility, and Importers of medical devices
Postmarket Surveillance
  • Postapproval Studies for various permanent
    implants after approval to monitor unexpected
  • Device Tracking - system for locating permanent
    implants/life-sustaining devices after they leave
    the hospital

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
  • Enforcement, when needed
  • Mitigating risks to the public health

Regulatory Requirements for Radiation-Emitting
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.
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
  • Televisions receivers and monitors (cathode ray
    tubes only)
  • X-ray security systems
  • Microwave ovens
  • Laser products ( CD players, light shows, welding
  • Metal halide lighting
  • Cordless and cellular telephones
  • Industrial RF sealers of plastics and laminates

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
  • 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

CT system as a radiation-emitting device
  • Comply with minimum radiation safety requirements
    of the performance standard (including labeling)
  • diagnostic x-ray systems
  • CT equipment
  • Manufacturers must provide certification meeting
    the standards.
  • Certification is not an FDA approval!
  • 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.

Regulations under the laws control the
  • 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
  • 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

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

2007 FDA Amendments ActMedical 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

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

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,
In Recent News.
FDA Proposes Mandatory Electronic Safety
ReportingNew Rules will Help Strengthen
Postmarket Safety Data Collection, August 20,
FDA to Review Medical Devices Marketed Prior to
1976 Action Addresses GAO Recommendation, April
9, 2009
Thank you!
  • Contact Information
  • Carole C. Carey
  • Director, CDRH International Staff
  • FDA Federal Research Center
  • at White Oak, WO 66, R-4618
    Direct 1- 301-796-5708
  • 10903 New Hampshire Ave.
    Fax 1- 301-847-8149
  • Silver Spring, MD 20993-0002
  • U.S.A