Presentation on theme: "How does the U.S. FDA Regulate Medical Devices?"— Presentation transcript:
1 How does the U.S. FDA Regulate Medical Devices? Carole C. CareyDirectorCDRH International StaffU.S. FDA Center for Devices and Radiological Health
2 Learning ObjectivesTo 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 doPremarketPostmarketEnforcement
5 U.S. Food and Drug Administration ScientificRegulatoryPublic Health Agencythat 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 CosmeticsCenter for Drugs & Evaluation Research (CDER)DrugsCenter for Biologics & Biologics Research (CBER)Biologics, VaccinesCenter for Veterinary Medicine (CVM)Animal Feed and DrugsCenter for Devices & Radiological Health (CDRH)Medical devicesRadiation- emitting productsCombination Products are (drug-device* biologic-device* drug-biologic)NEWLY Established!! FDA Center for Tobacco Products
7 Division of Small Manufacturers, International, andConsumer 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 arereasonably 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 1968Authority 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 devicesTitle 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 effectivenessUse valid scientific evidenceConsider least burdensome meansProvide “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 ActTwo pathways to marketShow 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 approvalGood manufacturing Practices
13 Examples of Device Classes Medical Device Classes:Class IGeneral ControlsMost exempt from premarket submissionClass IISpecial ControlsPremarket Notification [510(k)]Class IIIRequire Premarket Approval [PMA]
14 Sixteen Device Specialty Categories 21 CFR (part 800-1299) Medical Device Definition in Sec 201(h) of the FD&C Act862 Clinical chemistry and clinical toxicology864 Hematology and pathology866 Immunology and microbiology868 Anesthesiology870 Cardiovascular872 Dental874 Ear, nose and throat876 Gastroenterology & urology devices878 General and plastic surgery880 General hospital and personal use882 Neurological884 Obstetrical and gynecological886 Ophthalmic888 Orthopedic890 Physical medicine892 Radiology895 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 requirementDevices exempt from 510(k) are:“preamendment devices” not significantly changed or modified; orClass 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 exemptRegister and ListLabeling requirementsProhibit MisbrandingProhibit AdulterationQuality Systems /GMPRecords and Reports / (MDR)Report device failuresCorrective action plansBasic 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 devicesExisting 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 StudyPatient RegistriesGuidelines (e.g., Glove Manual)Mandatory Performance StandardRecommendations or Other ActionsSpecial 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 devicesNew, high-risk devices, may have new indications, predicate device does not applyLabeling, Instructions for Use, Training requirements
19 Risk-based Classification Level of Regulatory Control 1700 generic type of devices510(k) ExemptClass IClass IIClass III *Very lowLow (~782)Medium (~799)High (~119)General Controls (may or may not be GMP exempt)General ControlsPremarket Notification or 510(k)General & Special Controls510(k) submissionPremarket 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…BenefitsRisksHelping 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 eventsMandated postmarket surveillance for certain devicesFDA may order a recallEstablished humanitarian device exemption process1997 FDAMA ( FDA Modernization Act)Allows exemption of Class I devices“Third party” reviewRisk-based approach to postmarket surveillanceMedSun 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” classificationIf 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 devicesDown 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 appropriateWell documented case histories by qualified expertsOther valid scientific evidence, if acceptable (e.g., reports of significant human experience, non-clinical data, etc.).Does NOT includeIsolated case reportsRandom experienceReports lacking sufficient detailsUnsubstantiated opinions[§513(a)(3)]21 CFR 860.7
25 4. Consider Least Burdensome Means “Least Burdensome” concept, FDAMA 1997help 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.GuidanceThe 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 Interstateand Foreign Commerce, to accompany theMedical Device Amendments of 1976
27 “Total Product Life Cycle” Vision applied across Center activities
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 13485Standard 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 devicesEvents: Death, Serious Injury and MalfunctionReported by: Manufacturer, User Facility, and Importers of medical devices
31 Postmarket Surveillance Postapproval Studies for various permanent implants after approval to monitor unexpected problemsDevice 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 regulationsEnforcement, when neededMitigating 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 fromthe X-rays and produces images or picturesof cross-sections through the head or the body.Regulatory Requirements for Radiation-Emitting DevicesA 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 SunlampsUltrasound therapyLaser therapy and surgical devicesRadiation therapyMicrowave or ultrasound diathermy devicesMicrowave blood warmers or sterilizersUltraviolet dental curing devicesTelevisions receivers and monitors (cathode ray tubes only)X-ray security systemsMicrowave ovensLaser products ( CD players, light shows, welding lasers)Metal halide lightingCordless and cellular telephonesIndustrial RF sealers of plastics and laminates
35 CT System as a medical device Class II device (General & Special Controls)Submit Premarket notification or 510kMeet device safety & effectiveness requirements “substantially equivalent” in characteristics, performance and safetyManufacturer establishment registration & Device listingGood manufacturing practices/(QS) regulationsLabelingContinue to be cleared for marketing for general imaging purposesA 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) fordiagnostic x-ray systemsCT equipmentManufacturers 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 medicineLicense of the medical practitionersLicense 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 ReportsDocuments annual production, results of testing, and user safety concernsIn 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 FeeElectronic Registration and Listing SystemRequires Establishment of Unique Device Identification (UDI) systemStreamlines Inspection by Accredited PersonsPromotes Development of Pediatric DevicesFDAAA 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 bynew 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, 2009FDA to Review Medical Devices Marketed Prior to 1976 Action Addresses GAO Recommendation, April 9, 2009
42 Thank you!Contact InformationCarole C. CareyDirector, CDRH International StaffFDA Federal Research Centerat White Oak, WO 66, R Direct:10903 New Hampshire Ave Fax :Silver Spring, MDU.S.A