So allow devices to be labeled as "FDA approved" or "not evaluated by the FDA". Customers who value the FDA approved status can purchase those products. Customers who are comfortable determining the efficacy of a product via other means can purchase the non-evaluated products.
If no one purchases the non-evaluated product then the market will have spoken and the non-evaluated products will disappear. On the other hand if the non-evaluated products are successful then the market will have provided a better product.
If no one purchases the non-evaluated product then the market will have spoken and the non-evaluated products will disappear. On the other hand if the non-evaluated products are successful then the market will have provided a better product.