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Presented by Catherine Parker, RN Consumer Safety Officer

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Presented by Catherine Parker, RN Consumer Safety Officer Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological Health – PowerPoint PPT presentation

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Title: Presented by Catherine Parker, RN Consumer Safety Officer


1
Medical Devices, Device Regulations, and Medical
Device Trials
  • Presented by Catherine Parker, RN
  • Consumer Safety Officer
  • Division of Bioresearch Monitoring
  • Office of Compliance
  • Center for Devices and Radiological Health

2
Objectives
  • Define medical device
  • Describe the classifications of devices
  • Describe the ways a device can get to market
  • Describe how medical device clinical trials
    differ from drug trials

3
Medical Devices
4
Medical Device Definition
  • An instrument, apparatus, implement, machine,
    contrivance, implant, in vitro reagent, or other
    similar article, including any component, part,
    or accessory which is
  • Recognized in the official National Formulary, or
    the United States pharmacopeia, or any supplement
    to them
  • Intended for use in the diagnosis of disease or
    conditions, or in the cure, mitigation,
    treatment, or prevention of disease in man or
    other animals
  • Intended to affect the structure or any function
    of the body of man or other animals
  • Which does NOT achieve its primary intended
    purposes through chemical action within or on the
    body of man or other animals and which is NOT
    dependent upon being metabolized for the
    achievement of its intended purposes.
  • Definition of Device
  • Food Drug and Cosmetic Act 201(h)

5
The Important Points
  • Device definition excludes products that
  • Achieve their primary intended purpose through
    chemical action within the body
  • Are dependent upon being metabolized for the
    primary achievement of their primary intended
    purposes

6
Medical Devices are Classified by Risk
7
Class I Devices
  • General controls are sufficient to provide
    reasonable assurance of the safety and
    effectiveness
  • Examples elastic bandages, examination gloves,
    and hand-held surgical instruments

8
General Controls
  • Prohibition against adulterated or misbranded
    devices
  • Premarket notification 510(k) requirements
  • Good Manufacturing Practices (GMPs)
  • Labeling
  • Registration of manufacturing facilities
  • Listing of device types
  • Record keeping
  • Repair, replacement or refund

9
Class II Devices
  • .
  • General controls alone are insufficient to assure
    safety and effectiveness, and existing methods
    are available to provide such assurances.
  • Also subject to special controls
  • Examples powered wheelchairs, infusion pumps,
    and surgical drapes

10
Special Controls
  • Performance standards (discretionary, voluntary
    national or international standard, recognized by
    rulemaking)
  • Post-market surveillance
  • Patient registries
  • Development and dissemination of
    guidelines/guidances
  • Design controls
  • Recommendations and other appropriate actions
  • Tracking requirements

11
Class III Devices
  • Insufficient information exists to determine that
    general and special controls are sufficient to
    provide reasonable assurance of the safety and
    effectiveness of such devices
  • Such devices are
  • Life sustaining or life supporting
  • Substantial importance in preventing impairment
    of human health or
  • Present unreasonable risk of illness or injury

12
Getting a Device to Market
13
Premarket Notification 510(k)
21 C.F.R. 807
  • Used for devices that are substantially
    equivalent (SE) to a predicate device
  • Manufacturer must notify FDA 90 days before
    proposing to market a device
  • Burden is on the manufacturer to demonstrate that
    the device is SE.

The device is as safe and effective as an
existing marketed device.
14
Premarket Approval Application (PMA)
21 C.F.R. 814
  • Class III devices
  • New types of devices
  • Previously found not SE
  • May require pre-clinical and clinical data
    obtained from an investigational device exemption
    (IDE)

15
Humanitarian Device Exemption (HDE)
21 C.F.R. 814.100
  • Used for devices that will benefit patients with
    rare conditions (lt4,000 per year)
  • Application for HDE must demonstrate probable
    benefit
  • Devices must be used under IRB approval
  • Device must be available at cost

Vertical Expandable Prosthetic Titanium Rib By
Synthes
16
Other ways to Market
  • Product development protocol (PDP)
  • An alternative to a PMA whereby the
    investigation of a device and the development of
    information necessary for its approval are merged
    into one regulatory submission
  • De Novo classification pathway
  • A streamlined reclassification process for
    devices that are low-risk but not SE. They would
    automatically be assigned a Class III status. The
    de novo pathway can get a novel low-risk device
    reclassified to Class I or II thus avoiding a PMA

17
Custom Device
21 C.F.R. 812.3(b)
  • It is different from devices available
  • It is not available to, or used by other MDs or
    dentists
  • It is not available in finished form for purchase
    or dispensing upon prescription
  • It is not offered for commercial distribution
    through labeling or advertising
  • It is intended for use by an individual patient
    named in the order form
  • Made in a specific form for that patient or
  • Made to meet the special needs of MD or dentist
    (i.e. tool)

http//www.fda.gov/downloads/RegulatoryInformation
/Guidances/UCM127067.pdf
18
Medical Device Research
19
Research Applications
21 C.F.R. 812
  • Investigational Device Exemption (IDE)
  • Approved by an IRB and, if applicable, FDA
  • Informed consent from all subjects
  • Labeling for investigational use only
  • Monitoring of the study
  • Submission of required reports and records
  • Permits an unapproved device to be shipped
    lawfully

20
Device Clinical Research
  • Significant risk (SR)
  • IDE submission
  • Non-Significant risk (NSR)
  • Abbreviated requirements
  • IDE exempt

21
SR vs. NSR Determination
  • Decision based on use of device in study IDE
    submission
  • Sponsor makes initial assignment
  • IRB makes determination
  • FDA can disagree

22
Significant Risk Definition
  • Decision based on use of device in study
  • IDE application
  • Sponsor makes initial assignment
  • IRB makes determination
  • FDA can disagree

23
NSR Determination
  • No IDE application to FDA
  • Considered to have an IDE
  • Abbreviated requirements only

24
Abbreviated Requirements
21 C.F.R. 812.2(b)
  • Labels device
  • Obtains IRB approval
  • SR vs. NSR determination
  • Ensures informed consent
  • IRB may waive documentation of consent if
    minimal risk
  • Monitors study
  • Maintains records
  • Makes reports
  • Ensure CI maintains records and makes reports
  • Refrains from promotion and other practices

25
IDE Exempt Device Research
21 C.F.R. 812.2(c)
  • In commercial use before May 28, 1976
  • SE to device in commercial use before May 28,
    1976 and used or investigated for labeled
    indication
  • In vitro diagnostics (IVDs)
  • Consumer preference testing
  • Solely for veterinary or lab animal use

26
Access to Unapproved Devices
27
Early/Expanded Access
  • Emergency Use
  • Compassionate Use
  • Treatment Use
  • Continued Access

http//www.fda.gov/MedicalDevices/DeviceRegulation
andGuidance/HowtoMarketYourDevice/InvestigationalD
eviceExemptionIDE/ucm051345.htm
28
Emergency Use
  • Life-threatening or serious condition with no
    alternative
  • Before or during an IDE
  • FDA approval not required
  • Report to the IRB within 5 days
  • Report to the Sponsor and/or FDA

http//www.fda.gov/ScienceResearch/SpecialTopics/R
unningClinicalTrials/GuidancesInformationSheetsand
Notices/ucm118823.htm
29
Compassionate Use
  • Serious condition with no alternative
  • Before or during an IDE study
  • FDA approval required

http//www.fda.gov/MedicalDevices/DeviceRegulation
andGuidance/HowtoMarketYourDevice/InvestigationalD
eviceExemptionIDE/ucm051345.htmcontinuedaccess
30
Treatment Use
21 C.F.R. 812.36
  • Life-threatening or serious disease
  • No alternative
  • Controlled clinical trial
  • Sponsor pursuing marketing approval
  • FDA approval required

31
Continued Access
  • Public health need or
  • Preliminary evidence that the device will be
    effective with no significant safety concerns
  • Occurs after the completion of the clinical
    trial
  • FDA approval required

http//www.fda.gov/MedicalDevices/DeviceRegulation
andGuidance/HowtoMarketYourDevice/InvestigationalD
eviceExemptionIDE/ucm051345.htmcontinuedaccess
32
Trials
33
Regulatory Similarities in Trials
  • FDA approval required before test articles can be
    shipped
  • IDE or IND
  • FDA regulations specify sponsor and clinical
    investigator responsibilities
  • 21 CFR 812 and CFR 312

34
Regulatory Differences in Trials
  • Devices Investigator agreement generated by
    the sponsor per 21 CFR 812.43(c)
  • Drugs Statement of Investigator - Form 1572

35
Regulatory Differences in Trials
  • Contract Research Organizations (CRO)
  • Device regulations are silent about them
  • Drug regulations define transfer of obligations
    to CRO

36
Adverse Event Differences in Trials
  • Drugs
  • CI report any adverse effects that may
    reasonably be regarded as caused by, or probably
    caused by, the drug.
  • Sponsors notify FDA of any unexpected fatal or
    life-threatening event within 7 calendar days
  • Devices
  • CI report any unanticipated adverse device
    effects (UADE)
  • Sponsors report results of an evaluation of a
    UADE to FDA and all reviewing IRBs within 10
    working days

21 C.F.R. 812.150(a)(1)
21 C.F.R.312.32
37
Medical Device Trials
  • Subject population usually in the 100s rather
    than 1000s
  • No phases Feasibility then pivotal study
  • Blinding is less common
  • Controls vary
  • No placebo rather sham, active, historical
  • CI training often critical (e.g. Human Factors)
  • IRBs play a critical role

38
Summary
39
Other References
  • CDRH Homepage
  • www.fda.gov/cdrh
  • CDRH Learn
  • http//www.fda.gov/Training/CDRHLearn/ucm162015.ht
    m
  • Device Advice
  • www.fda.gov/cdrh/devadvice
  • Computerized Systems
  • http//www.fda.gov/downloads/Drugs/GuidanceComplia
    nceRegulatoryInformation/Guidances/UCM070266.pdf

40
Device Contacts for Questions
  • Questions related to compliance
  • Cathy Parker, Office of Compliance, Division of
    Bioresearch Monitoring, 301-796-5553
  • Questions pertaining to SR/NSR
  • Office of Device Evaluation
  • Program Operation Staff 240-276-4040
  • IRB or Human Subject Protections Marian Serge,
    301-796-5644
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