FDA Requires Premarket Approval for Penile Inflatable Implant

Summary

The Food and Drug Administration (FDA) is issuing a final rule requiring the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the penile inflatable implant, a device intended to treat erectile dysfunction, in order to comply with the Federal Food, Drug, and Cosmetic Act and Congress' requirement for premarket review of class III devices.