H jattani healthcare_apps_fda_02.19.11
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H jattani healthcare_apps_fda_02.19.11 H jattani healthcare_apps_fda_02.19.11 Presentation Transcript

  • Medical App Development and FDA
    By HarshaJattani
    harsha.jattani@gmail.com
    Astute BioSolutions
    www.astutebiosolutions.com
  • Computing Trends: Then and now
  • Advent of Mobile Healthcare and Mobile App Development
  • Healthcare apps may be required to undergo FDA clearance
    Why?
    FDA may view healthcare apps as medical devices. According to the FDA…
    “A medical device is an instrument, apparatus, implement, software, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.”
    (Excerpt from FDA website)
  • Is this app a medical device?
    Exposure to blue light is effective in treating seasonal affective disorder. This mobile app displays blue light to aid in the treatment of seasonal affective disorder.
    YES! This app claims it can be used to treat a disease. This app falls under the jurisdiction of the FDA.
  • Is this app a medical device?
    Exposure to blue light has the ability to calm and soothe. This mobile app displays blue light to induce calm and soothing moods.
    NO! This app does not claim to treat a disease. This app does not fall under the jurisdiction of the FDA.
  • Competitive market advantage
    The same app can be classified as a medical device or escape the medical device classification simply based on the app claims!
    Obtaining FDA clearance lengthens product time-to-market but offers the app developer a competitive market advantage. He/she has demonstrated to the FDA the ability of the app to treat a condition. Why would a consumer wish to purchase a competitor’s product that is NOT FDA cleared?
  • FDA Regulatory Process
    Two Common Regulatory Pathways:
    510(k)
    • For low to moderate risk devices that have a predicate device
    • Most healthcare apps fall into this category
    • Cost ~$5000
    • FDA decision time: 90 days
    Premarket Approval
    • Reserved for significant risk products or those that do not have a predicate device
    • Cost ~$200,000
    • FDA decision time: 180 days
  • Requirements for Software Regulatory Submissions
    The following are some of the common components for a 510(k) regulatory submission for a software product:
    • Software Requirement Specification
    • Traceability
    • Verification and Validation Testing
    • Labeling
  • Any questions?
    Thank you !
    http://www.astutebiosolutions.com