Drug delivery or combination device applications include a variety of therapies that range from long term implantable, short term implantable, inserted or skin contact devices. Common examples include steroid eluting electrodes, hormone replacement or contraceptive implants, ophthalmic implants, implantable sensors, and reservoirs. By combining device design with select raw materials and optimized process parameters, short or long term elution profiles can be achieved to meet the desired performance criteria.
Combination products typically fall into one of two categories, if the device is the primary motive action and the drug is secondary then representatives from the device side of the FDA will usually be assigned lead the regulatory assessment with support from CDER (Center for Drug evaluation and Research), if the drug is the primary contributor, then CDER usually is the lead organization.