u.s. food and drug administration center for devices and radiological health 2009 sep 29 edmonton,...

U.S. Food and Drug Administration Center for Devices and Radiological Health 2009 Sep 29 Edmonton, Oct 1 Vancouver

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

Carole C. Carey Carole C. Carey

DirectorDirector

CDRH International StaffCDRH International Staff

U.S. FDA Center for Devices and U.S. FDA Center for Devices and Radiological HealthRadiological Health

22U.S. Food and Drug Administration Center for Devices and Radiological Health 2009 Sept 8-10

Learning ObjectivesLearning Objectives

To have an awareness and basic To have an awareness and basic understanding of the FDA’s legal authority, understanding of the FDA’s legal authority, regulatory framework, principles, and regulatory framework, principles, and approach in the management and approach in the management and supervision of medical devices & radiation-supervision of medical devices & radiation-emitting devices marketed in the U.S.emitting devices marketed in the U.S.


OutlineOutline

Who are we?Who are we?

What, who and why do we regulate?What, who and why do we regulate?

How do we do it?How do we do it?

What we doWhat we do– PremarketPremarket– Postmarket Postmarket – EnforcementEnforcement


Department of Health & Human Services


U.S. Food and Drug AdministrationU.S. Food and Drug Administration

ScientificScientificRegulatory Regulatory Public Health AgencyPublic Health Agency

that oversees items accounting for 25 cents that oversees items accounting for 25 cents of every dollar spent by consumersof every dollar spent by consumers. .

Protect and Promote Public Health.Protect and Promote Public Health.

http://www.fda.gov/http://www.fda.gov/


U.S. FDA Centers U.S. FDA Centers and Regulated Productsand Regulated Products

Center for Food Safety & Center for Food Safety & Nutrition (CFSAN)Nutrition (CFSAN)– Food and CosmeticsFood and Cosmetics

Center for Drugs & Evaluation Center for Drugs & Evaluation Research (CDER)Research (CDER)– DrugsDrugs

Center for Biologics & Center for Biologics & Biologics Research (CBER)Biologics Research (CBER)– Biologics, VaccinesBiologics, Vaccines

Center for Veterinary Medicine Center for Veterinary Medicine (CVM)(CVM)– Animal Feed and DrugsAnimal Feed and Drugs

Center for Devices & Center for Devices & Radiological Health Radiological Health (CDRH)(CDRH)– Medical devicesMedical devices– Radiation- emitting Radiation- emitting

productsproducts– Combination Products Combination Products

are (drug-deviceare (drug-device* * biologic-biologic-devicedevice** drug-biologic)drug-biologic)

NEWLY Established!!NEWLY Established!! FDA Center for Tobacco FDA Center for Tobacco ProductsProducts


Acting Center Director Dr. J. Shuren

Office of Device Evaluation (ODE) Office of Compliance (OC)

Office of Science and Engineering Laboratories (OSEL)

Office of Surveillanceand 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, andConsumer Assistance [email protected]


U.S. Medical Device IndustryU.S. Medical Device Industry

Smallest Smallest FirmsFirms

Employees Per Firm*

* Source: Census Bureau, Number of Firms, Number of Establishments, Employment, and Annual Payroll by * 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, Employment Size of the Enterprise for the United States, All Industries 2005 using NAICS codes 339111,339112, 339113, 339114, 339115, 339116, 334517, 334510, 325413 339113, 339114, 339115, 339116, 334517, 334510, 325413 http://www.census.gov/csd/susb/susb05.htm

According to the US Census Bureau, there are over 12,000 medical device According to the US Census Bureau, there are over 12,000 medical device manufacturing firms in the US.*manufacturing firms in the US.*

3443%

4544%

1,40511%

1,33411%

8,82971%

<1010-1920-99100-499500+


FDA CDRH Regulates All FDA CDRH Regulates All Medical Devices in the U.S.Medical Devices in the U.S.

““CDRH CDRH protects American protects American citizenscitizens go about their go about their daily lives with safety daily lives with safety measures in place so that measures in place so that medical devicesmedical devices and and radiological productsradiological products are are

reasonably safe and effectivereasonably safe and effective as intended.”as intended.”

Medical Medical devicesdevices Pacemakers, Contact Pacemakers, Contact Lenses, Hearing Aids...Lenses, Hearing Aids...In-vitro diagnostic In-vitro diagnostic devices devices (lab tests and (lab tests and home use tests)home use tests)Radiation-Emitting Radiation-Emitting Products Products Lasers, Lasers, Microwaves... Microwaves... Combination ProductsCombination Products Drug eluting stents…Drug eluting stents…


Legal Framework: FDA’s AuthorityLegal Framework: FDA’s Authority

Federal Food Drug and Federal Food Drug and Cosmetic Act (FDCA)Cosmetic Act (FDCA)

Medical Device Medical Device Amendments (MDA) Act Amendments (MDA) Act ***May 28, 1976*** ***May 28, 1976***

Radiation Control for Radiation Control for Health and SafetyHealth and Safety Act of Act of 19681968

– Authority to protect Authority to protect unnecessary human unnecessary human exposure to radiation exposure to radiation from medical and non-from medical and non-medical products in the medical products in the home, industry. home, industry.

The Code of Federal The Code of Federal Regulations (CFR) Regulations (CFR)

Title 21 Code of Federal Title 21 Code of Federal Regulations Regulations Parts 800 – 1299Parts 800 – 1299 medical devicesmedical devices

Title 21 of the Code of Title 21 of the Code of Federal RegulationsFederal RegulationsParts 1000 – 1050Parts 1000 – 1050 electronic product electronic product radiationradiation


Regulatory ApproachRegulatory Approach

1.1. Base degree of control on riskBase degree of control on risk

2.2. Weigh probable benefit vs. risk to determine Weigh probable benefit vs. risk to determine safety and effectivenesssafety and effectiveness

3.3. Use valid scientific evidenceUse valid scientific evidence

4.4. Consider least burdensome meansConsider least burdensome means

5.5. Provide “reasonable assurance”Provide “reasonable assurance”


1. Three Tier Classification Scheme1. Three Tier Classification Scheme

““Medical devices are classified into 3 classes Medical devices are classified into 3 classes and regulated according to their and regulated according to their complexity complexity and and degree of risk to the public healthdegree of risk to the public health.”.”

1976 Medical Device Amendments Act1976 Medical Device Amendments Act

Two pathways to marketTwo pathways to market– Show as safe and as effective as device on the Show as safe and as effective as device on the

market on May 28, 1976; (510k) or premarket market on May 28, 1976; (510k) or premarket notification.notification.

– Prove device is safe and effective; (PMA) or Prove device is safe and effective; (PMA) or premarket approvalpremarket approval

Good manufacturing PracticesGood manufacturing Practices


Examples of Device ClassesExamples of Device Classes

Medical Device Classes:Medical Device Classes:

Class I Class I

General ControlsGeneral Controls

Most exempt from premarket submissionMost exempt from premarket submission

Class IIClass II

Special ControlsSpecial Controls

Premarket Notification [510(k)]Premarket Notification [510(k)]

Class IIIClass III

Require Premarket Approval [PMA] Require Premarket Approval [PMA]


Sixteen Device Specialty CategoriesSixteen Device Specialty Categories21 CFR (part 800-1299)21 CFR (part 800-1299)

862862 Clinical chemistry and Clinical chemistry and clinical toxicologyclinical toxicology

864864 Hematology and Hematology and pathologypathology

866866 Immunology and Immunology and microbiologymicrobiology

868868 Anesthesiology Anesthesiology

870870 Cardiovascular Cardiovascular

872872 Dental Dental

874874 Ear, nose and throat Ear, nose and throat

876876 Gastroenterology & Gastroenterology & urology devicesurology devices

878878 General and plastic General and plastic surgerysurgery

880880 General hospital and General hospital and personal usepersonal use

882882 Neurological Neurological

884884 Obstetrical and Obstetrical and gynecologicalgynecological

886886 Ophthalmic Ophthalmic

888888 Orthopedic Orthopedic

890890 Physical medicine Physical medicine

892892 Radiology Radiology

Medical Device Definition in Sec 201(h) of the FD&C Act

895 Banned devices


Class I / II ExemptionsClass I / II ExemptionsFD&C Act 513(d)(2A)FD&C Act 513(d)(2A)

Over 800 generic types of Class I devices Over 800 generic types of Class I devices and 60 Class II devices are exempted from the premarket and 60 Class II devices are exempted from the premarket notification requirement notification requirement

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm

Devices Devices exemptexempt from 510(k) are: from 510(k) are:– ““preamendment devicespreamendment devices” not significantly changed or ” not significantly changed or

modified; or modified; or – Class I/II devices specifically Class I/II devices specifically exempted by regulationexempted by regulation..

510(k) Exempt Devices - approximately 47%510(k) Exempt Devices - approximately 47%Class IClass I - 93% (stethoscope, spectacle lens/frame)- 93% (stethoscope, spectacle lens/frame)Class IIClass II - 9% (radiologic table, dental noble metal alloy) - 9% (radiologic table, dental noble metal alloy)

Not all Exempt devices are exempt from GMPNot all Exempt devices are exempt from GMP


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

Basic authoritiesBasic authorities that that

provide FDA with the means provide FDA with the means

to regulate medical devices.to regulate medical devices.

Applies to Applies to all medical all medical

devicesdevices regardless of regardless of

classification; all subject to classification; all subject to

premarket and postmarket premarket and postmarket

regulatory controls.regulatory controls.

– Premarket notification or Premarket notification or

510(k), if not exempt510(k), if not exempt

– Register and List Register and List

– Labeling requirementsLabeling requirements

Prohibit MisbrandingProhibit Misbranding

– Prohibit AdulterationProhibit Adulteration

– Quality Systems /GMPQuality Systems /GMP

– Records and Reports / (MDR)Records and Reports / (MDR)

Report device failures Report device failures

Corrective action plansCorrective action plans


What are Special Controls?What are Special Controls?(Class II devices)(Class II devices)

Postmarket Surveillance Postmarket Surveillance StudyStudy

Patient RegistriesPatient Registries

Guidelines (e.g., Glove Guidelines (e.g., Glove

Manual)Manual)

Mandatory Performance Mandatory Performance

StandardStandard

Recommendations or Recommendations or

Other ActionsOther Actions

Special Labeling (e.g., Special Labeling (e.g.,

882.5970, Cranial Orthosis)882.5970, Cranial Orthosis)

General controls alone are General controls alone are insufficient to assure safety and insufficient to assure safety and effectiveness of Class II deviceseffectiveness of Class II devices

Existing methods are available Existing methods are available to provide such assurances. to provide such assurances.

Special controls may include Special controls may include special labeling requirements, special labeling requirements, mandatory performance mandatory performance standards, tracking and standards, tracking and postmarket surveillance.postmarket surveillance.

A few Class II devices are exempt A few Class II devices are exempt from the premarket notification.from the premarket notification.


Class III Premarket ApprovalClass III Premarket Approval

A demonstration of safety and effectiveness supported A demonstration of safety and effectiveness supported by component level tests, bench tests, clinical data (may by component level tests, bench tests, clinical data (may include animal study)include animal study)

IDE (investigational device exemption) allows study of IDE (investigational device exemption) allows study of unapproved devicesunapproved devices

New, high-risk devices, may have new indications, New, high-risk devices, may have new indications, predicate device does not applypredicate device does not apply

Labeling, Instructions for Use, Training requirementsLabeling, Instructions for Use, Training requirements


Risk-based ClassificationRisk-based ClassificationLevel of Regulatory ControlLevel of Regulatory Control

510(k) Exempt510(k) Exempt Class IClass I Class IIClass II Class III *Class III *

Very lowVery low Low (~782)Low (~782) Medium (~799)Medium (~799) High (~119)High (~119)

General Controls General Controls (may or may not (may or may not be GMP exempt) be GMP exempt)

General ControlsGeneral Controls

Premarket Premarket Notification or Notification or 510(k)510(k)

General & General & Special ControlsSpecial Controls

510(k) 510(k) submission submission

General & General & Special ControlsSpecial Controls

Premarket Premarket Approval (PMA)Approval (PMA)

1700 generic type of devices


2. Balancing Risks and Benefits2. Balancing Risks and Benefits

Getting Getting safe safe and effective and effective devicesdevices to to market as market as quickly as quickly as possible…possible…

Getting Getting safe safe and effective and effective devicesdevices to to market as market as quickly as quickly as possible…possible…

… … while while keeping keeping

unsafe and unsafe and ineffective ineffective devices outdevices out

of the of the market.market.

… … while while keeping keeping

unsafe and unsafe and ineffective ineffective devices outdevices out

of the of the market.market.

Helping the public get Helping the public get science-based accurate science-based accurate informationinformation about medical devices and radiological about medical devices and radiological

products needed to improve health.products needed to improve health.


CDRH Health MilestonesCDRH Health Milestones“practicing risk-based”“practicing risk-based”

1990 SMDA1990 SMDA (Safe (Safe Medical Devices Act)Medical Devices Act)

– Required user facilities Required user facilities (hospitals) to report (hospitals) to report adverse eventsadverse events

– Mandated postmarket Mandated postmarket surveillance for certain surveillance for certain devicesdevices

– FDA may order a recallFDA may order a recall

– Established humanitarian Established humanitarian device exemption processdevice exemption process

1997 FDAMA1997 FDAMA ( FDA ( FDA Modernization Act)Modernization Act)

– Allows exemption of Class I Allows exemption of Class I devicesdevices

– ““Third party” review Third party” review

– Risk-based approach to Risk-based approach to postmarket surveillancepostmarket surveillance

– MedSun Program (a MedSun Program (a network of reporting network of reporting facilities)facilities)

– Quality System Regulation Quality System Regulation effectiveeffective


Reclassification, another Reclassification, another

example of risk-based approachexample of risk-based approach

As experience and knowledge about a device increase, As experience and knowledge about a device increase, FDA may calibrate theFDA may calibrate the original classificationoriginal classification and and readjustreadjust based on FDA’s receipt of new information.based on FDA’s receipt of new information.

May be an “up” classification or a “down” classificationMay be an “up” classification or a “down” classification

If If reclassifiedreclassified to a lower class, must convince the FDA to a lower class, must convince the FDA that less stringent class requirements will be sufficient to that less stringent class requirements will be sufficient to provide reasonable assurance of safety and effectivenessprovide reasonable assurance of safety and effectiveness..


Example of “Down” ClassificationExample of “Down” Classification

Arrhythmia detectors and alarmsArrhythmia detectors and alarms were were originally classified as originally classified as Class IIIClass III devices devices

Down classified to Down classified to Class II with special controlsClass II with special controls sufficient to mitigate risks to patients.sufficient to mitigate risks to patients.

““Guidance for Industry and FDA Staff - Class II Special Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Arrhythmia Detector and Controls Guidance Document: Arrhythmia Detector and Alarm” (Alarm” (October 28, 2003)October 28, 2003)

It is important to describe what is to be It is important to describe what is to be reclassified.reclassified.


3. Use valid scientific evidence3. Use valid scientific evidence

Effectiveness is to be determined by:Effectiveness is to be determined by:

Well-controlled investigationsWell-controlled investigationsOne or more clinical investigations where appropriateOne or more clinical investigations where appropriate

Well documented case histories by qualified experts Well documented case histories by qualified experts

Other valid scientific evidence, if acceptable (e.g., reports Other valid scientific evidence, if acceptable (e.g., reports of significant human experience, non-clinical data, etc.). of significant human experience, non-clinical data, etc.).

Does NOT includeDoes NOT include– Isolated case reportsIsolated case reports– Random experienceRandom experience– Reports lacking sufficient detailsReports lacking sufficient details– Unsubstantiated opinionsUnsubstantiated opinions

[§513(a)(3)]21 CFR 860.7


4. Consider Least Burdensome Means4. Consider Least Burdensome Means

““Least Burdensome” concept, Least Burdensome” concept, FDAMA 1997FDAMA 1997

– help to expedite the availability of new device technologies help to expedite the availability of new device technologies without compromising scientific integrity in the decision-making without compromising scientific integrity in the decision-making process or FDA’s ability to protect the public health. process or FDA’s ability to protect the public health.

GuidanceGuidance

The Least Burdensome Provisions of the FDA Modernization Act The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and of 1997: Concept and Principles; Final Guidance for FDA and IndustryIndustry

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085994.htmGuidanceDocuments/ucm085994.htm


5. Provide “reasonable assurance”5. Provide “reasonable assurance”

““No regulatory mechanism can guarantee that a product No regulatory mechanism can guarantee that a product will never cause injury, or will always produce effective will never cause injury, or will always produce effective

results. Rather, the objective of the legislation is . . . results. Rather, the objective of the legislation is . . . reasonable assurance that medical devices are safe and reasonable assurance that medical devices are safe and

effective.”effective.”

-- Report by the House Committee on Interstate -- Report by the House Committee on Interstate

and Foreign Commerce, to accompany the and Foreign Commerce, to accompany the

Medical Device Amendments of 1976Medical Device Amendments of 1976


““Total Product Life Cycle” Vision Total Product Life Cycle” Vision applied across Center activitiesapplied across Center activities

Enabling Enabling TechnologyTechnology

and Innovationand Innovation

Enabling Enabling TechnologyTechnology

and Innovationand Innovation

Efficient, Efficient, Effective, Effective,

and Predictable and Predictable Product Product

DevelopmentDevelopment

Efficient, Efficient, Effective, Effective,

and Predictable and Predictable Product Product

DevelopmentDevelopment

Ensuring Ensuring the Safety ofthe Safety of Marketed Marketed

Medical DevicesMedical Devices

Ensuring Ensuring the Safety ofthe Safety of Marketed Marketed

Medical DevicesMedical Devices


Postmarketing RequirementsPostmarketing Requirements

Quality System/GMPQuality System/GMP

Adverse Event ReportingAdverse Event Reporting

Postmarket surveillancePostmarket surveillance


Quality System (QS) Quality System (QS) Regulation (21 CFR Part 820)Regulation (21 CFR Part 820)

Quality Assurance System covering the design Quality Assurance System covering the design and manufacture of medical devices sold in and manufacture of medical devices sold in the U.S.the U.S.

Similar to ISO 13485Similar to ISO 13485

Standard for audit of device establishmentStandard for audit of device establishment


Medical Device Reporting (MDR)Medical Device Reporting (MDR)“Adverse Event Reporting”“Adverse Event Reporting”

(21 CFR Part 803)(21 CFR Part 803)

Mechanism for FDA to identify and monitor Mechanism for FDA to identify and monitor significant adverse events involving medical significant adverse events involving medical devicesdevices

Events: Death, Serious Injury and Malfunction

Reported by: Manufacturer, User Facility, and Importers of medical devices


Postmarket SurveillancePostmarket Surveillance

Postapproval StudiesPostapproval Studies for various permanent for various permanent implants after approval to monitor unexpected implants after approval to monitor unexpected problemsproblems

Device TrackingDevice Tracking - system for locating - system for locating permanent implants/life-sustaining devices permanent implants/life-sustaining devices after they leave the hospitalafter they leave the hospital


Enforcement and the Office of Compliance

Ensuring compliance with applicable Ensuring compliance with applicable laws and regulationslaws and regulations

Enforcement, when neededEnforcement, when needed

Mitigating risks to the public healthMitigating risks to the public health

Protect the public health by ensuring that device and radiological health products are safe and effective by:

U.S. Food and Drug Administration Center for Devices and Radiological Health 2009 Sep 29 Edmonton, Oct 1 Vancouver

Regulatory Requirements for Regulatory Requirements for Radiation-Emitting DevicesRadiation-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.


Medical and Non-Medical Medical and Non-Medical ProductsProducts

SunlampsSunlampsUltrasound therapyUltrasound therapyLaser therapy and Laser therapy and surgical devicessurgical devicesRadiation therapyRadiation therapyMicrowave or ultrasound Microwave or ultrasound diathermy devicesdiathermy devicesMicrowave blood Microwave blood warmers or sterilizerswarmers or sterilizersUltraviolet dental curing Ultraviolet dental curing devicesdevices

Televisions receivers and Televisions receivers and monitors (cathode ray monitors (cathode ray tubes only)tubes only)X-ray security systemsX-ray security systemsMicrowave ovensMicrowave ovensLaser products ( CD Laser products ( CD players, light shows, players, light shows, welding lasers)welding lasers)Metal halide lightingMetal halide lightingCordless and cellular Cordless and cellular telephonestelephonesIndustrial RF sealers of Industrial RF sealers of plastics and laminatesplastics and laminates


CT System as a medical deviceCT System as a medical device

Class II device (General & Special Controls)Class II device (General & Special Controls)

Submit Premarket notification or 510kSubmit Premarket notification or 510k– Meet device safety & effectiveness requirements “substantially Meet device safety & effectiveness requirements “substantially

equivalent” in characteristics, performance and safetyequivalent” in characteristics, performance and safety

Manufacturer establishment registration & Device listing Manufacturer establishment registration & Device listing

Good manufacturing practices/(QS) regulationsGood manufacturing practices/(QS) regulations

LabelingLabeling– Continue to be cleared for marketing for general imaging Continue to be cleared for marketing for general imaging

purposes purposes

– A new indication such as CT scanning for whole-body screening A new indication such as CT scanning for whole-body screening for individuals without symptoms will require a PMAfor individuals without symptoms will require a PMA


CT system as a CT system as a radiation-emitting deviceradiation-emitting device

Comply with minimum Comply with minimum radiation safety radiation safety requirements of the requirements of the performance standardperformance standard (including labeling) for (including labeling) for – diagnostic x-ray systemsdiagnostic x-ray systems

– CT equipmentCT equipment

Manufacturers must Manufacturers must provide provide certification certification meeting the standards.meeting the standards.– Certification is not an FDA Certification is not an FDA

approval!approval!

21 CFR PART 1020 21 CFR PART 1020 Performance Standards for Performance Standards for ionizing radiationionizing radiation

§ 1020.10§ 1020.10 - Television - Television receivers.receivers.§ 1020.20§ 1020.20 - Cold-cathode gas - Cold-cathode gas discharge tubes.discharge tubes.§ 1020.30§ 1020.30 - - Diagnostic x-ray Diagnostic x-ray systems and their major systems and their major components.components.§ 1020.31§ 1020.31 - Radiographic - Radiographic equipment.equipment.§ 1020.32§ 1020.32 - Fluoroscopic - Fluoroscopic equipment.equipment.§ 1020.33§ 1020.33 - - Computed Computed tomography (CT) tomography (CT) equipment.equipment.§ 1020.40§ 1020.40 - Cabinet x-ray - Cabinet x-ray systems.systems.


Regulations under the laws Regulations under the laws control the requirementscontrol the requirements

The The responsibilityresponsibility for the safety regulation of for the safety regulation of radiation-emitting electronic products radiation-emitting electronic products is sharedis shared..

FDA regulatesFDA regulates the level of controls and requirements on the level of controls and requirements on the the manufacturemanufacture of the CT systems. of the CT systems.

The The useuse of CT systems of CT systems for medical purposesfor medical purposes is is controlled, in the U.S. largely at the controlled, in the U.S. largely at the state & local state & local government levelgovernment level..

Practice of medicine Practice of medicine

License of the medical practitionersLicense of the medical practitioners

License or register facilities operating x-ray systemLicense or register facilities operating x-ray system


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

21 CFR 1002.10, 11, 12 21 CFR 1002.10, 11, 12 Product ReportsProduct Reports (Initial, (Initial, Supplemental, Abbreviated)Supplemental, Abbreviated)

– Documents information on manner of conformity to Documents information on manner of conformity to standards, labeling, test instrumentation, test standards, labeling, test instrumentation, test procedures, quality control, procedures, quality control,

– Must be submitted at least one month before actual Must be submitted at least one month before actual shipment to commerce.shipment to commerce.

21 CFR 1002.13 21 CFR 1002.13 Annual ReportsAnnual Reports – Documents annual production, results of testing, and Documents annual production, results of testing, and

user safety concernsuser safety concerns

In our case example, a CT system will require an Initial, In our case example, a CT system will require an Initial, Supplemental and Annual ReportsSupplemental and Annual Reports


2007 FDA Amendments Act2007 FDA Amendments ActMedical Device ProvisionsMedical Device Provisions

2007 Amendments, Medical Device User Fee 2007 Amendments, Medical Device User Fee

Electronic Registration and Listing SystemElectronic Registration and Listing System

Requires Establishment of Unique Device Identification Requires Establishment of Unique Device Identification (UDI) system(UDI) system

Streamlines Inspection by Accredited PersonsStreamlines Inspection by Accredited Persons

Promotes Development of Pediatric DevicesPromotes Development of Pediatric Devices

FDAAA sunsets on October 01, 2012FDAAA sunsets on October 01, 2012


To summarize, in the U.S. all To summarize, in the U.S. all medical devices are regulated by FDAmedical devices are regulated by FDA

A risk-basedA risk-based regulatory paradigm is used to regulatory paradigm is used to establish establish reasonable assurance of safety and reasonable assurance of safety and effectivenesseffectiveness. .

The law gives us the flexibility to balance out our regulatory way The law gives us the flexibility to balance out our regulatory way of thinking to the level of potential risk posed by of thinking to the level of potential risk posed by

new products,new products,

new technology,new technology,

inspections,inspections,

postmarket surveillance, etc.postmarket surveillance, etc.


In Recent News….In Recent News….

FDA to Review Medical Devices FDA to Review Medical Devices Marketed Prior to 1976 Marketed Prior to 1976 Action Action Addresses GAO Recommendation, Addresses GAO Recommendation, April 9, 2009April 9, 2009

FDA Proposes Mandatory Electronic Safety ReportingNew Rules will Help Strengthen Postmarket Safety Data Collection, August 20, 2009


Thank you!Thank you!

Contact InformationContact Information

Carole C. CareyCarole C. CareyDirector, CDRH International StaffDirector, CDRH International Staff

FDA Federal Research Center FDA Federal Research Center at White Oak, WO 66, R-4618 Direct: 1- 301-796-5708 at White Oak, WO 66, R-4618 Direct: 1- 301-796-5708 10903 New Hampshire Ave. Fax : 1- 301-847-814910903 New Hampshire Ave. Fax : 1- 301-847-8149 Silver Spring, MD 20993-0002 [email protected] Silver Spring, MD 20993-0002 [email protected]

U.S.AU.S.A

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