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Entering the US Market: Medical Devices Carole C. Carey BSEE, M.Engineering Director, International Staff US Food and Drug Administration.

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Presentation on theme: "Entering the US Market: Medical Devices Carole C. Carey BSEE, M.Engineering Director, International Staff US Food and Drug Administration."— Presentation transcript:

1 Entering the US Market: Medical Devices Carole C. Carey BSEE, M.Engineering Director, International Staff US Food and Drug Administration Center for Devices and Radiological Health

2 2 Topics Brief FDA Organizational Structure Regulatory Paradigm, Device Classification Two Most Common Pathways to Market Levels of Regulatory Control (General Controls & Special Controls) Importing into the U.S. CDRH Databases and Resources

3 3 The U.S. Food and Drug Administration is Scientific, Regulatory, Public Health Agency Mission is to protect and promote public health. Authority to regulate medical devices Federal FD&C Act Established regulatory controls for medical devices (May 28, 1976) 21 CFR Parts

4 4 Department of Health & Human Services

5 5 FDA Centers and Regulated Products Food Drugs Medical Devices * Biologics Animal Feed and Drugs Cosmetics Radiation-Emitting Products * Combination Products (drug-device*, biologic- device*, drug-biologic) Primary mode of action RFD (Request for Designation) FDA CDRH Center for Devices and Radiological Health CBER Center for Biologics and Evaluation Research CFSAN Center for Food Safety and Applied Nutrition NCTR National Center for Toxicological Research CVM Center for Veterinary Medicine CDER Center for Drugs and Evaluation Research * Office of Regulatory Affairs (ORA) is the lead office for all field activities.

6 6 Center Director Dr. Daniel Schultz Office of Device Evaluation ODE Office of Compliance (OC) Office of Science and Engineering Laboratories (OSEL) Office of Surveillance and Biometrics (OSB) Office of Communication, Education and Radiation Programs (OCER) * International Affairs Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) CDRH

7 7 16 Classification Regulations 21 CFR (part ) Clinical chemistry and clinical toxicology Hematology and pathology Immunology and microbiology Anesthesiology Cardiovascular Dental Ear, nose and throat Gastroenterology & urology devices General and plastic surgery General hospital and personal use Neurological Ophthalmic Orthopedic and physical medicine Obstetrical and gynecological Radiology Medical Device Definition in Sec 201(h) of the FD&C Act

8 8 Regulatory Paradigm: Balancing Risks and Benefits Getting safe and effective devices to market as quickly as possible… … while ensuring that devices currently on the market remain safe and effective. Helping the public get science-based accurate information about medical devices and radiological products needed to improve health.

9 9 Risk-based Classification, Level of Reg Control, & Submission Type 510(k) Exempt Class IClass IIClass III Very lowLow (~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 1700 generic type of devices Level of Risk & Level of Regulatory Control

10 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 I93% Class II 9% Devices exempt from 510(k) are: preamendment devices not significantly changed or modified; or Class I/II devices specifically exempted by regulation.

11 11 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]

12 12 What are General Controls? 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. Establishment registration and device listing Premarket notification or 510(k), if not exempt Labeling Misbranding Adulteration Quality Systems Records and Reports / Medical Device Reporting (MDR)

13 13 What are Special Controls? Postmarket Surveillance Study Patient Registries Guidelines (e.g., Glove Manual) Mandatory Performance Standard Recommendations or Other Actions Special Labeling (e.g., , Cranial Orthosis) 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 and postmarket surveillance. A few Class II devices are exempt from the premarket notification.

14 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 equivalence Class 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 15 Use of Consensus Standards & Guidance Documents CDRH Standards Program Guidance Documents They are non-binding but very useful in streamlining the regulatory approval process.

16 16 Legal Import of Medical Devices into the U.S. Market Section 801(a) – (d) of the FD&C Act Subject 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 Registration Medical Device Listing Compliant Labeling GMP/Quality Systems Appropriate Marketing Applications unless exempt 510(k) PMA Adverse Event Reporting, Records/Complaint Files

17 17 Summary If 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 CDRHs 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 18 CDRH manages risk across the Total Product Life Cycle applied across Center activities

19 19 CDRH Databases Registration and Listing Premarket Approvals (PMA) Premarket Notifications (510(k)) Product Classification FDA-Recognized Consensus Standards MAUDE (Manufacturer and User Facility Device Experience) MDR (Medical Device Reporting) and others…

20 20 Division of Small Manufacturers, International and Consumer Assistance (DSMICA) Fax(00) Phone(00) Write to us at: International Staff, Center for Devices and Radiological Health, HFZ Piccard Drive Rockville, MD USA Device Advice (a self- service, interactive Site)


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