The FDA defines a medical device as
- “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a 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 a 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.”
The above information pertains to the Federal Food and Drug Administration (FDA). The FDA regulates medical devices to ensure that all medical devices are safe for use on people.
At This Moment Zona Shoppers is not Accepting FDA Approval Required Listings
Products Approved for Listings
All products must display the expiration date.
All products must include a detailed description for buyers to understand the use and management.
Products must be listed within at least 90 days prior to the expiration date.
Expired, used, open package products are prohibited from being listed on Zona Shoppers.
- Authorized FDA over the counter (OTC) products that are not restricted and are appropriately described and labeled, for example, but not limited to:
- Adhesive bandages
- Crutches
- Pill containers
- Eyeglass frames
- Vintage or collectible medical devices, but listings must state that these are not intended for use.
Rules to list Over the Counter Products
- The product must be new, sealed package, and unopened.
- The product must display an expiration date of at least 90 days.
- The product’s active ingredients, including the amount in each dosage unit.
- The purpose of the product.
- The uses (indications) for the product.
- Specific warnings, including when the product should not be used under any circumstances and when it is appropriate to consult with a doctor or pharmacist. This section also describes side effects that could occur and substances or activities to avoid.
- Dosage instructions–when, how, and how often to take the product.
- The product’s inactive ingredients, important information to help consumers avoid ingredients that may cause an allergic reaction.
- The label also requires a type size large enough to be easily read and specific layout details–bullets, the spacing between lines, and clearly marked sections–to improve readability.
