Regulating Wireless Devices

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Regulating Wireless Devices

• David 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
• Postmarket surveillance
• Guidance documents
• Clinical data, special labeling, warnings,
  precautions, contraindications
• Patient registries
• Tracking, Adverse Events

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Class III Devices

• lt10 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

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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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My Contact Information

• David Arvelo, SBR
• FDA/ORA/SWRO (HFR-SW2)4040 N. Central
  ExpresswaySuite 900Dallas, TX 75204
• Telephone [phone]
• Fax [phone]
• Email david.arvelo_at_fda.hhs.gov