Overview of Device Regulations
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Overview of Device Regulations David Arvelo Small Business Representative
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Overview of Device Regulations. David Arvelo Small Business Representative. Total Product Life Cycle. Device Classification System. Increases with level of risk Class I Class II Class III Determines level of regulation applied to the device. Class I Devices. 46% of all devices - PowerPoint PPT Presentation
Transcript of Overview of Device Regulations
Overview of Device RegulationsDavid Arvelo
Small Business Representative
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Total Product Life Cycle
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Device Classification System
• Increases with level of risk• Class I• Class II• Class III
• Determines level of regulation applied to the device
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Class I Devices
• 46% of all devices• Low-risk devices
• Surgical instruments, wound dressings, toothbrush
• General Controls• Most are exempt
from Premarket Notification, 510(k)
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General Controls
• Establishment Registration• Medical Device Listing• Good Manufacturing Practice (Quality
System Regulation)• Device labeling• Premarket proof of safety and
effectiveness, i.e., 510(k)
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Class II Devices
• 47% of all devices• Moderate-risk devices
• E.g., blood pressure cuffs, vascular clamps, sutures, aneurysm clips, oximeters, urology catheters, cautery devices
• General and Special Controls• Most not exempt from Premarket
Notification, 510(k)
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Special Controls
• Performance standards• Guidance documents
• Clinical data, special labeling, warnings, precautions, contraindications
• Postmarket surveillance • Patient registries
• Tracking, Adverse Events
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Class III Devices
• <10% of all devices• Moderate and high risk devices
• Pacemakers, breast implants, vascular grafts, lithotripters, lasers
• General Controls, Special Controls, and Premarket Approval (PMA)
• Clinical data needed (IDE)
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Device Categories
• 1746 Categories• 786 Class I
• 729 exempt from 510(k)
• 860 Class II• 68 exempt from
510(k)
• 100 Class III
0
100
200
300
400
500
600
700
800
900
1000
Class I Class II Class III
Exempt
Non-exempt
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Quality System Guidance
• Medical Device Quality Systems Manual: A Small Entity Compliance Guide
• FDA 97-4179• Available free online
at www.fda.gov
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www.fmdic.org
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DSMICA
• Division of Small Manufacturers, International, and Consumer Assistance• Device Advice• CDRH Learn• CDRH Databases
• Toll-free in the USA 1-800-638-2041• Email [email protected]
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Office of Combination Products
• FDA assistance and guidance for manufacturers of drug/device/biologic combination medical products
• Phone 301-796-8930• Fax 301-847-8619• Email [email protected]• http://www.fda.gov/CombinationProducts/
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My Contact Information
• David Arvelo, SBR• FDA/ORA/SWRO (HFR-SW2)
4040 N. Central ExpresswaySuite 900Dallas, TX 75204
• Telephone 214-253-4952• Fax 214-253-4970• Email [email protected]
