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Non-Invasive Neuromodulation of the Central Nervous System Opportunities and Challenges: Workshop Summary (2015) / Chapter Skim
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8 Regulatory Issues
Pages 57-64

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From page 57...
... • For sponsors seeking regulatory approval of devices in the United States, the FDA has encouraged the use of new tools, including innovative clinical trial designs, such as adaptive trials as well as modeling and simulation. (Connor)
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From page 58...
... Their different paths to device approval have resulted in varying availability in different countries. For example, while the Neuronetics Neuro-Star system for the treatment of depression received FDA approval in 2008, CE Mark approval1 was not obtained until 2012 (PR Newswire, 2012)
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From page 59...
... Non-medical devices are not subject to EC regulations; however, Hannah Maslen noted that the European Commission has proposed a revision of the Medical Devices Directive that would include a new annex covering implantable and invasive devices with a non-medical purpose. ENSURING SAFETY AND EFFICACY Regulators' primary concern is ensuring that products reaching the market demonstrate both efficacy and safety.
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From page 60...
... In 2012, the FDA issued a Guidance on Factors to consider when making benefit-risk determinations in medical device premarket approval and de novo classifications (FDA, 2012)
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From page 61...
... Jason Connor, an adaptive clinical trial designer with Berry Consultants, addressed issues related to clinical trials for neurostimulatory devices. Connor serves on the FDA's Neurologic Devices Advisory Panel.
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From page 62...
... Connor noted that these tools allow investigators to simulate different population groups, different levels of effectiveness of the device, different dose−response curves, and different study designs enabling trials to be tailored to a specific patient population where a benefit is most likely to be seen. Simulations also allow key stakeholders to imagine why the trial might fail and what could have been done differently, for example, by changing dose, selecting a different study population, etc.
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From page 63...
... More generally, he said that for any marketed product that seems, for all intents and purposes, as if it should be considered a medical device, there may be an ongoing action or correspondence, but this also would be confidential. Krauthamer added that the regulatory science group does not typically look at specific devices, but only general endpoint; examples include running animal and cell tissue experiments at the field strengths covered by a range of devices, but not specifically that device.
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From page 64...
... 64 NON-INVASIVE NEUROMODULATION or if it is still "in limbo." Marjenin said that unless the FDA has weighed in on it, consumers would not be able to find out.
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Key Terms

  • trial design
  • neurostimulatory devices
  • medical device
  • neuromodulatory devices
  • special controls

  • clinical trials
  • neurostimulation devices
  • establish special
  • medical devices
  • trial designs

  • regulatory approval
  • devices branch
  • critical path
  • class iii
  • competent authorities

  • european commission
  • maslen noted
  • premarket approval
  • depression received
  • fda issued

  • regulators typically
  • specific devices
  • overestimate treatment
  • product safety
  • safety concern

  • lies primarily
  • particularly cdrh
  • devices facing
  • device properly
  • notified bodies


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