[Verified Answer]: Dr. Smith is participating in a clinical trial

Dr. Smith is participating in a clinical trial of an investigational implanted device for epilepsy. He has a subject with intractable seizures who has not responded to approved therapy. He wants to enroll the subject in the clinical trial but notes that the subject does not meet inclusion criteria because she has undergone several excluded treatments. Which answer describes the best way for Dr. Smith to provide the device to the subject: Contact the IRB to see if it will approve a waiver of the exclusion criteria Implant the device in the subject because no other treatment is available Contact the device manufacturer to discuss the possibility of obtaining a treatment IDE for the subject Contact the FDA to obtain a treatment IDE for the subject