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NM Bio Overview of Medical Device Regulations.ppt

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					Overview of Device Regulations
                             David Arvelo
            Small Business Representative
Total Product Life Cycle




                           2
Device Classification System

• Increases with level of risk
  • Class I
  • Class II
  • Class III
• Determines level of regulation applied
  to the device



                                           3
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)

                            4
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)

                                         5
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)
                                            6
Special Controls

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


                                                 7
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)


                                            8
Device Categories

• 1746 Categories
  • 786 Class I
     • 729 exempt from
       510(k)
  • 860 Class II
     • 68 exempt from
       510(k)
  • 100 Class III




                         9
10
Quality System Guidance

• Medical Device
  Quality Systems
  Manual: A Small
  Entity Compliance
  Guide
• FDA 97-4179
• Available free online
  at www.fda.gov


                          11
www.fmdic.org




            12
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
                                        13
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/


                                            14
My Contact Information

• David Arvelo, SBR
• FDA/ORA/SWRO (HFR-SW2)
  4040 N. Central Expressway
  Suite 900
  Dallas, TX 75204
• Telephone 214-253-4952
• Fax 214-253-4970
• Email david.arvelo@fda.hhs.gov
                                   15

				
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posted:1/22/2014
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