H jattani healthcare_apps_fda_02.19.11
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Transcript of H jattani healthcare_apps_fda_02.19.11
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:1. 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
2. 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
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