Channels to Purchase
Dispensus plans to sell AVA in superstores, pharmacies, and sporting goods stores. Based on market analysis, the team identified that AVA customers will likely frequent these locations.
Regulatory Strategy
According to the medical device definition as indicated by the Food and Drug Administration, AVA is not a classified medical device, thus will not require FDA approval.
- An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- 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, or
- Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
Intellectual Property
Provisional Patent Filed – Patent Pending