Experience in Moving Neurological Medical Devices From Bench to Market
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1 Experience in Moving Neurological Medical Devices From Bench to Market Cogni;ve Func;on following concussion Abla;on Therapy Clot Retriever for Ischemic Stroke Prosthe;c Arm Medical Device For Migraine Microcatheters for the neurovasculature 1
2 Regulatory Pathways for Medical Devices Sponsors Apply to FDA to Market Device FDA Decision Points PreMarket Approval (PMA) Submission 180* Days NonClinical & Clinical Study Phase May occur over mul;ple years of development De Novo Submission 120* Days Premarket No9fica9on 510(k) Sponsors submit a presubmission to the FDA to start early regulatory discussions and develop a path forward 90* Days Humanitarian Device Exemp9on Legally Marketed in the United States 75* Days *Number of days noted is days the submission is under review by the FDA, not the total time that it may take to get the device technology to market or through the review process. In some cases, the review process may take longer depending upon the particular device, technology, indication for use, user, and risk of the device. 2
3 A Few Medical Device Regulatory Concepts Device classifica;on is based on risk Weigh benefit vs. risk to determine safety and effec;veness Use valid scien9fic evidence Provide reasonable assurance of safety and effec;veness Consider least burdensome means Assess based on the indica9on for use 3
4 Mobile Medical Apps Guidance (2015) Mobile Medical Applica;ons: Guidance for Industry and Food and Drug Administra;on Staff Purpose: Provide clarity and predictability for manufacturers of mobile medical apps Provide informa;on on FDA s current thinking hkps:// UCM pdf 4 4
5 General Wellness Guidance (2016) Finalized July 2016 hkp:// deviceregula;onandguidance/guidancedocuments/ucm pdf Purpose-Provide dray guidance on general wellness products that present a very low risk to users safety and are for: An intended use that relates to a maintaining or encouraging a general state of health or a healthy ac;vity, or An intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or condi;ons and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condi;on. 5
6 Benefit Risk Considera9ons (2016) Factors to Consider When Making Benefit-Risk Determina;ons in Medical Device Premarket Approvals and De Novo Classifica;ons ( hkps:// deviceregula;onandguidance/guidancedocuments/ucm pdf) What are the probable benefits? Type, magnitude, dura;on, etc. What are the probable risks? Type, severity, probability, dura;on, etc. Addi;onal Factors, such as: Uncertainty Pa;ent tolerance for risk and perspec;ve on benefit Alterna;ves Etc. 6
7 21 Century Cures Act Codifies FDA Policies The new law amended the defini;on of device in the Food, Drug and Cosme;c Act to exclude certain soyware func;ons intended... (A) for administra/ve support; (B) for maintaining or encouraging a healthy lifestyle; (C) to serve as a electronic pa/ent records; (D) for transferring, storing, conver/ng formats, or displaying clinical laboratory test or other device data and results and certain other related informa/on; and (E) to provide recommenda/ons to health care professionals for clinical decisions, where the user can independently review the basis of the recommenda/on. 7
8 The Pre-Submission Program Guidance Issued February 18, 2014 An opportunity to obtain FDA feedback prior to clinical study or marke9ng submission Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Mee;ngs with Food and Drug Administra;on Staff 8 8
9 Biofeedback device Neurodiagnostics External func9onal neuros9mulator Depth Electrode Thermal system for insomnia Concussion cogni*ve assessment device Cogni9ve devices Cor9cal Electrode Electroencephalogram (EEG) Near Infrared Brain Hematoma Detector Brain injury interpre9ve EEG Neurological Devices Transcutaneous electrical nerve s9mulator for headache Neurotherapeutic Devices Neuropsychiatric EEG Computerized Cogni9ve Assessment Assessment Aid Cranial Electrotherapy s9mulator Repe99ve TMS Physiological Signal Amplifier Alpha Monitor Transcutaneous electrical nerve stimulator for pain relief9
10 It s About the Pa;ents Carlos Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evalua;on Center for Devices and Radiological Health carlos.pena@fda.hhs.gov 10
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