1. 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

2. 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 & radiation-emitting devices marketed in the U.S.

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

4. Department of Health & Human Services

5. 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.

6. 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 Products

7. Division of Small Manufacturers,
International, and
Consumer Assistance

8. U.S. Medical Device Industry
According to the US Census Bureau, there are over 12,000 medical device manufacturing firms in the US.*
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 ,339112, , , , , , ,

9. 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.”
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…

10. 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.
The Code of Federal Regulations (CFR)
Title 21 Code of Federal Regulations Parts 800 – medical devices
Title 21 of the Code of Federal Regulations Parts 1000 – electronic product radiation

11. 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”

12. 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

13. 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]

14. 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
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

15. 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
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

16. What are General Controls? (Class I, II, III devices)
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.

17. 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 assurances.
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., , Cranial Orthosis)

18. 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

19. 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 Controls (may or may not be GMP exempt)
General Controls
Premarket Notification or 510(k)
General & Special Controls
510(k) submission
Premarket Approval (PMA)

20. 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…
Benefits
Risks
Helping the public get science-based accurate information about medical devices and radiological products needed to improve health.

21. CDRH Health Milestones “practicing risk-based”
1990 SMDA (Safe Medical Devices Act)
Required user facilities (hospitals) to report adverse events
Mandated postmarket surveillance for certain devices
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 facilities)
Quality System Regulation effective

22. 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.

23. 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.

24. 3. Use valid scientific evidence
Effectiveness is to be determined by:
Well-controlled investigations One or more clinical investigations where appropriate
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
[§513(a)(3)]
21 CFR 860.7

25. 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

26. 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

27. “Total Product Life Cycle” Vision applied across Center activities

28. Postmarketing Requirements
Quality System/GMP
Adverse Event Reporting
Postmarket surveillance

29. 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

30. 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

31. 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

32. 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

33. Regulatory Requirements for Radiation-Emitting Devices
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
A CT scan is a special X-ray examination, where a computer collects the information from the X-rays and produces images or pictures of cross-sections through the head or the body.
diagnostic imaging procedure that uses x rays to obtain cross-sectional images of the body. Since its introduction and rapid adoption into medicine in the mid-1970s, CT has become recognized as a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

34. 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 lasers)
Metal halide lighting
Cordless and cellular telephones
Industrial RF sealers of plastics and laminates

35. 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

36. 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!
21 CFR PART 1020 Performance Standards for ionizing radiation
§ Television receivers.
§ Cold-cathode gas discharge tubes.
§ Diagnostic x-ray systems and their major components.
§ Radiographic equipment.
§ Fluoroscopic equipment.
§ Computed tomography (CT) equipment.
§ Cabinet x-ray systems.

37. 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

38. Reporting Requirements Applies to products listed in Table 1 of 21CFR, 1002.1
21 CFR , 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 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

39. 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

40. 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.

41. In Recent News….
FDA Proposes Mandatory Electronic Safety Reporting New Rules will Help Strengthen Postmarket Safety Data Collection, August 20, 2009
FDA to Review Medical Devices Marketed Prior to 1976 Action Addresses GAO Recommendation, April 9, 2009

42. Thank you!
Contact Information
Carole C. Carey
Director, CDRH International Staff
FDA Federal Research Center
at White Oak, WO 66, R Direct:
10903 New Hampshire Ave Fax :
Silver Spring, MD
U.S.A