Presentation on theme: "Entering the US Market: Medical Devices"— Presentation transcript:
1 Entering the US Market: Medical Devices Carole C. Carey BSEE, M.EngineeringDirector, International StaffUS Food and Drug AdministrationCenter for Devices and Radiological Health
2 Topics Brief FDA Organizational Structure Regulatory Paradigm, Device ClassificationTwo Most Common Pathways to MarketLevels of Regulatory Control (General Controls & Special Controls)Importing into the U.S.CDRH Databases and ResourcesOrganizational structure, mission, authority, CDRH risk-based regulatory paradigm, TPLCDefinition of a medical device (3 steps to obtain marketing clearance – medical device? class, application)New vs. Improved DeviceDevice classification – preamendment (predicate devices) and postamendment [513g request for classification and 513f deNovo]Forms (R&L, fees, etc)Investigational studies (IDE)
3 The U.S. Food and Drug Administration is Scientific, Regulatory, Public Health AgencyMission is to protect and promote public health.Authority to regulate medical devicesFederal FD&C ActEstablished regulatory controls for medical devices (May 28, 1976)21 CFR PartsFDA MissionFDA's public health protection role and mission were incorporated into the Federal Food, Drug, and Cosmetic Act by the FDA Modernization Act of 1997 (PL ). The Act outlined bold and innovative approaches to meet the increasingly complex public health challenges of the 21st century. FDA is committed to the successful implementation of this plan and believes success is within reach with the resources and support of its stakeholders. The FDA's statutory mission is:To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner. With respect to such products, to protect the public health by ensuring that:foods are safe, wholesome, sanitary, and properly labeled;human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labeled, and; public health and safety are protected from electronic product radiation. To participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and, As determined to be appropriate by the Secretary of the Department of Health and Human Services, to carry out these activities in consultation with experts in science, medicine, and public health and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products.Edited 3/1/2000
5 FDA Centers and Regulated Products *FoodDrugs Medical Devices *BiologicsAnimal Feed and DrugsCosmeticsRadiation-Emitting Products *Combination Products (drug-device*, biologic-device*, drug-biologic)Primary mode of actionRFD (Request for Designation)OriginsThe U S. Food and Drug Administration is a scientific, regulatory, and public health agency that oversees items accounting for 25 cents of every dollar spent by consumers. Its jurisdiction encompasses most food products (other than meat and poultry), human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products for consumer, medical, and occupational use, cosmetics, and animal feed. The agency grew from a single chemist in the U.S. Department of Agriculture in 1862 to a staff of approximately 9,100 employees and a budget of $1.294 billion in 2001, comprising chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, lawyers, and many others. About one-third of the agency's employees are stationed outside of the Washington, D. C. area, staffing over 150 field offices and laboratories, including five regional offices and 20 district offices. Agency scientists evaluate applications for new human drugs and biologics, complex medical devices, food and color additives, infant formulas, and animal drugs. Also, the FDA monitors the manufacture, import, transport, storage, and sale of about $1 trillion worth of products annually at a cost to taxpayers of about $3 per person. Investigators and inspectors visit more than 16,000 facilities a year, and arrange with state governments to help increase the number of facilities checked.HISTORYThe legislation having failed to develop, the Secretary of HEW commissioned the Study Group on Medical Devices, which recommended in 1970 that medical devices be classified according to their comparative risk, and regulated accordingly. The 1976 Medical Device Amendments, coming on the heels of a therapeutic disaster in which thousands of women were injured by the Dalkon Shield intrauterine device, provided for three classes of medical devices, each requiring a different level of regulatory scrutiny--up to pre-market approval.1976MEDICAL DEVICE AMENDMENTS passed to ensure safety and effectiveness of medical devices, including diagnostic products. The amendments require manufacturers to register with FDA and follow quality control procedures. Some products must have pre-market approval by FDA; others must meet performance standards before marketing.Office of Regulatory Affairs (ORA)is the lead office for all field activities.
7 16 Classification Regulations 21 CFR (part 800-1299) Clinical chemistry and clinical toxicologyHematology and pathologyImmunology and microbiologyAnesthesiologyCardiovascularDentalEar, nose and throatGastroenterology & urology devicesGeneral and plastic surgeryGeneral hospital and personal useNeurologicalOphthalmicOrthopedic and physical medicineObstetrical and gynecologicalRadiologyMedical Device Definition in Sec 201(h) of the FD&C Act
8 Regulatory Paradigm: Balancing Risks and Benefits … while ensuring that devices currently on the market remain safe and effective.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.
9 Risk-based Classification, Level of Reg Control, & Submission Type 1700 generic type of devices510(k) ExemptClass IClass IIClass IIIVery 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 Approval1700 generic types of devices16 classification regulations21 CFRe.g. 870 = CardiovascularClassification determines extent of regulatory controlLevel of Risk & Level of Regulatory Control
10 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 (Federal Register)510(k) Exempt Devices - approximately 47%Class I 93%Class II 9%Devices exempt from 510(k) are:“preamendment devices” not significantly changed or modified; orClass I/II devices specifically exempted by regulation.The Food, Drug and Cosmetic Act under section 513(d)(2)(A) authorizes FDA to exempt certain generic types of Class I devices from the premarket notification [510(k)] requirement. FDA has exempted over 800 generic types of Class I devices and 60 class II devices from the premarket notification requirement. The 510(k) exemption is with certain limitations, which are so noted in ".9" of each chapter. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts or the PRODUCT CODE CLASSIFICATION DATABASE or subsequent FR announcements on class I exemptions and class II exemptions. If a manufacturer's device falls into a generic category of exempted Class I devices as defined in 21 CFR Parts , a premarket notification application and FDA clearance is not required before marketing the device in the U.S.
11 Examples of Device Classes Medical Device Classes:Class IGeneral ControlsMost exempt from premarket submissionClass IISpecial ControlsPremarket Notification [510(k)]Class IIIRequire Premarket Approval [PMA]
12 What are General Controls? Establishment registration and device listingPremarket notification or 510(k), if not exemptLabelingMisbrandingAdulterationQuality SystemsRecords and Reports / Medical Device Reporting (MDR)Basic authorities that provide FDA with the means to regulate medical devices.Applies to all medical devices regardless of classification, are subject to premarket and postmarket regulatory controls.Generally synonymous to Class I device. General controls include:Establishment Registration (use FDA Form 2891) of companies which are required to register under 21 CFR Part , such as manufacturers, distributors, repackages and relabelers. Foreign establishments, however, are not required to register their establishments with FDA.Medical Device Listing (use FDA Form 2892) with FDA of devices to be marketed.Manufacturing devices in accordance with Good Manufacturing Practices (GMP) in 21 CFR Part 820.Labeling devices in accordance with labeling regulations in 21 CFR Part 801 or 809.Submission of a premarket notification [510(k)] before marketing a device.Misbranding is False or Misleading labelingManufacturers. Importers and distributors must maintain records of reports to assure that devices are not adulterated and misbranded
13 What are Special Controls? 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 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)Class II - Special ControlsClass II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls.A few Class II devices are exempt from the premarket notification.Special controls may include special labeling requirements, mandatory performance standards and postmarket surveillance.Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.
14 Two Most Common Pathways to Market in the U.S. Premarket Notification (PMN or 510(K))Safe and effective to a legally marketed (predicate) device through demonstration of substantial equivalenceClass I, II, or III (pre-amendment)Premarket Approval (PMA)Demonstration of safety and effectiveness (supported by clinical data)Class III (new, high risk devices and no predicate device, new indications)The primary regulation that allows to conduct clinical trials using unapproved medical devices in the U.S. without complying with the FD&C Act is… the IDE or Investigational Device Exemption (21 CFR Part 812)
15 Use of Consensus Standards & Guidance Documents CDRH Standards ProgramGuidance DocumentsThey are non-binding but very useful in streamlining the regulatory approval process.
16 Legal Import of Medical Devices into the U. S Legal Import of Medical Devices into the U.S. Market Section 801(a) – (d) of the FD&C ActSubject to examination by FDA even if the product is authorized for marketing in another country.Devices must be safe and effective.Must contain informative and truthful labeling in English.Imported products are required to meet the same standards as domestic goods.Establishment RegistrationMedical Device ListingCompliant LabelingGMP/Quality SystemsAppropriate Marketing Applications unless exempt510(k)PMAAdverse Event Reporting, Records/Complaint Files
17 SummaryIf a product is labeled, promoted or used in a manner defined in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act, it will be regulated by the FDA as a medical device.USFDA CDRH’s regulatory paradigm is risk-based classification. The levels of regulatory control are based on the classification. Unless exempt, they require a premarket notification clearance or a premarket approval application.In entering the U.S. medical device market,First determine if it meets definition of medical device.Then determine how the may FDA classify the device, if known.Finally, gather your information, collect the necessary data, organize your submission.Products imported into the U.S. meets the same standards and requirements as domestic goods.
18 CDRH manages risk across the “Total Product Life Cycle” applied across Center activities TOTAL PRODUCT LIFE CYCLE MODEL (TPLC) is applied across Center activities to promote and protect the public heath.Total Product Life Cycle (TPLC) is an integrated product development scheme and a conceptual framework for assessing a variety of industrial and clinical models. For the manufacturer TPLC is the market-driven evolution of a device, drug, or biologic from initial conception, through pre-market development, to widespread market use, and finally to obsolescence and replacement by subsequent generations of products.
19 CDRH Databases http://www.fda.gov/cdrh/databases.html Registration and ListingPremarket Approvals (PMA)Premarket Notifications (510(k))Product ClassificationFDA-Recognized Consensus StandardsMAUDE (Manufacturer and User Facility Device Experience)MDR (Medical Device Reporting) ’92-’96and others…
20 “Device Advice” (a self-service, interactive Site) Division of Small Manufacturers, International and Consumer Assistance (DSMICA)Fax (00)Phone (00)Write to us at:International Staff, Center for Devicesand Radiological Health, HFZ-2201350 Piccard DriveRockville, MD USA“Device Advice” (a self-service, interactive Site)