Overview of Device Regulations David Arvelo Small Business Representative

2 Total Product Life Cycle

3 Device Classification System Increases with level of risk Class I Class II Class III Determines level of regulation applied to the device

4 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)

5 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)

6 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)

7 Special Controls Performance standards Guidance documents Clinical data, special labeling, warnings, precautions, contraindications Postmarket surveillance Patient registries Tracking, Adverse Events

8 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)

9 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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11 Quality System Guidance Medical Device Quality Systems Manual: A Small Entity Compliance Guide FDA Available free online at

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13 DSMICA Division of Small Manufacturers, International, and Consumer Assistance Device Advice CDRH Learn CDRH Databases Toll-free in the USA

14 Office of Combination Products FDA assistance and guidance for manufacturers of drug/device/biologic combination medical products Phone Fax

15 My Contact Information David Arvelo, SBR FDA/ORA/SWRO (HFR-SW2) 4040 N. Central Expressway Suite 900 Dallas, TX Telephone Fax