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

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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 Industry.Devices@fda.hhs.gov

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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 combination@fda.gov• 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 david.arvelo@fda.hhs.gov