Center for Devices and Radiological Health CDRH

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Center for Devices and Radiological Health (CDRH)

• Device Issues
• Non-Significant Risk Studies
• Custom Devices
• Humanitarian Use Devices
• In Vitro Diagnostic Devices

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Non-Significant Risk Device Study

• Regulation 21 CFR 812.66
• Guidance FDA Information Sheets
• Sponsors will necessarily make the NSR decision
  when developing their research plan for a device
• IRBs must review each NSR device research study
  and determine whether it is a NSR or SR
• FDA is available to help and its determination is
  final

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NSR Device Study

• IRB Responsibilities
• Follow written procedures that describe how Board
  will make the SR/NSR determination 21 CFR 108
  (a)
• Record determination in meeting minutes 21 CFR
  56.115 (a)
• Report to investigator and where appropriate the
  sponsor
• 21 CFR 108 (a)

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NSR Device Study

• Inspectional technique
• Ask IRB for list of NSR device studies
• Copy the list, including protocol title, sponsor,
  clinical investigator, etc.
• Attach as an exhibit to the EIR
• Review meeting minutes of the NSR studies and
  determine if IRB followed procedures and
  regulations

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Custom Device

• Federal Food, Drug, and Cosmetic Act, Sec.
  520(b)
• Code of Federal Regulations
• 21 CFR 812.3 (b)

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The ActSection 520 (b)

• Sec. 514 (standards), and 515 (class III) do not
  apply to any device which, in order to comply
  with the order of an individual physician or
  dentist, necessarily deviates from an otherwise
  applicable performance standard or requirement
  prescribed at section 515 if
• 1) the device is not generally available in
  finished form and not offered through labeling or
  advertising by the manufacturer for commercial
  distribution.

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The ActSection 520 (b)

• 2) the device is intended for use by an
  individual patient named in the order by the
  physician and is to be made in a specific form
  for the patient, or
• It is intended to meet the special needs of such
  physician or dentist, and
• It is not generally available to or generally
  used by other physicians.

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Regulations 21 CFR 812.3Definition of Custom
DeviceRepeats info in the act

• Necessarily deviates from devices generally
  available
• Not generally available to physicians
• Not generally available for purchase
• Not offered for commercial distribution

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21CFR 812.3Custom Device

• Is intended for use by an individual patient
  named in the order of a physician or dentist, or
  is made in a specific form for that patient, or
  is intended to meet the special needs of the
  physician or dentist in the course of
  professional practice

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Example of Custom Device

• External pacemaker needed for a fetus
• Lead is only made as single lumen, 6 Fr.
• Physician approached the manufacturer to design
  and make a double lumen, size 3 French, for use
  in a fetus.
• The manufacturer had to construct this device.
• Used for one unique situation for one specific
  subject

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3 Examples when a device is not a Custom Device

• Hydrocephalic shunts made of some other material
  than silicone because patients allergic to
  silicone. (IDE needed)
• Cranial helmets for miss-shaped new- born heads.
  The helmets are shaped or sized i.e. fitted for
  each subject. (IDE needed)
• Thoracic Aortic Aneurysm graft ordered
  individually for each patient (IDE needed)

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Custom Device Issues

• Must not be used to circumvent the regs
• State of the art new technology device
• Used for unique medical anomaly
• One subject use
• No data collected. It is not research.
• After Custom use, if there is interest to pursue
  research, then IDE necessary.
• Custom device may be class 2 or 3.

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Inspectional Technique

• Sponsor site ask if the sponsor has filled any
  requests to make a custom device.
• Investigator site ask if the investigator has
  used a custom device.
• IRB ask the IRB if it has had the occasion to
  review requests to use custom device. Review is
  not required by regulations, but an investigator
  may have approached the IRB

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Humanitarian Use DeviceHUD

• Regulation 21 CFR 814 Subpart H Humanitarian
  Device Exemption (HDE)
• Reporting adverse events 21 CFR 803 Medical
  Device Reports
• Guidance Http//www.fda/gov/cdrh/ode/hdeinfo.html
  

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Definition of HUD

• Device intended to benefit patients in the
  treatment and diagnosis of diseases or conditions
  that affect fewer than 4,000 individuals in the
  U.S.
• The device would not be available except through
  HUD
• Probable benefit outweighs the risk

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Humanitarian Use Device

• IRB responsibilities 814.124
• Initial review at a convened meeting
• Continuing review
• IRB reports the withdrawal of approval to the
  sponsor
• Clinical Investigator responsibilities (814.126)
• Report Adverse Events on MDR (ref 21CFR 803)
• Report Adverse Events to IRB

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HUD Guidance

• Addresses sponsor and IRB issues
• IRB issues
• if appropriate, continuing review may be done by
  expedited review.
• Informed consent Although neither the act nor
  the regulation requires informed consent, the
  IRB, institution, or state may require one
• Guidance is under consideration for revision
  because of the following issues
• Question 18 appears to limit practice of
  medicine
• Question 23 inappropriately included emergency
  use
• Question 24 inappropriately included
  compassionate use
• AND no guidance on MDR reporting

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Recent HUD Compliance Issue

• Practice of medicine
• TheraSphere HUD
• DBM sent IRBs an educational letter MDR
  reporting and research of new uses require an IDE
• Federal Food, Drug and Cosmetic Act Sec. 906
• Nothing in this Act shall be construed to limit
  or interfere with the authority of a health care
  practitioner to prescribe or administer any
  legally marketed device to a patient for any
  condition or disease within a legitimate health
  care practitioner-patient relationship.

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HUD Issues

• Sponsors and investigators cannot promote the off
  label use of an HUD
• Any research, i.e., collection of safety or
  effectiveness data of the HUD for uses not
  described in labeling must have an IDE.
• Investigators must report AEs on MDR
• Sponsors required to submit reports to FDA

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In Vitro Diagnostic Studies

• Office of In Vitro Diagnostics, CDRH
• IRB review is necessary
• Informed consent is necessary
• When stored samples are used the sponsor should
  call OIVD for advice