definiens: shall mean a drug delivery device that meets all of the following criteria : ( A ) it has a core within a polymer layer that contains a drug in a form other than a CODRUG(TM ) and no other active ingredient, where the core does not include a CODRUG(TM ), ( B ) it is Approved or designed to be Approved ( 1 ) to deliver a corticosteroid and no other active ingredient by implantation, injection, or other direct delivery method to the posterior portion of the eye, or ( 2 ) to treat DME by delivering a compound or formulation by implantation, injection, or other direct delivery method other than through an incision smaller than that required for a 25 gauge needle, ( C ) it does not fall under the definition of Excluded Product, and ( D ) it is Approved or designed to be Approved for a particular indication in a particular country . For clarification, eye drops or other topical administration and tablets or other oral administration shall not be deemed to be direct delivery to the posterior portion of the eye . For example, shall specifically include a drug delivery device that meets all of the following criteria ( such product sometimes referred to as the ): ( 1 ) consists of [ * ] ( 2 ) is Approved or designed to be Approved to be administered [ * ] ; ( 3 ) is Approved or designed to be Approved [ * ] and ( 4 ) is Approved or designed to be Approved for a particular indication in a particular country . For clarification, with regard to the same drug delivery device described above, each indication in each country shall be a separate Product . By way of non‐limiting examples, with regard to a particular drug delivery device X, ( i ) X for DME and X for age‐related macular degeneration shall be two different Products, and ( ii ) X for DME in the United States and X for DME in Japan shall be two different Products