IDE application filed 12/29/14 and today marked 30 full days since filing. So I expect to hear tomorrow at 7:15am that the FDA IDE submission has been either approved, approved with conditions or disapproved. Should be interesting day either way! NEXT STEP:
Once an IDE application is approved, the following requirements must be met in order to conduct the investigation in compliance with the IDE regulations:
•Labeling - The device must be labeled in accordance with the labeling provisions of the IDE regulations (§812.5) and must bear the statement "CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use."
•Distribution - Investigational devices can only be distributed to qualified investigators §812.43(b).
•Informed Consent - Each subject must be provided with and sign an informed consent form before being enrolled in the study. 21 CFR 50, Protection of Human Subjects, contains the requirements for obtaining informed consent.
•Monitoring - All investigations must be properly monitored to protect the human subjects and assure compliance with approved protocols under §812.46.
•Prohibitions - Commercialization, promotion, and misrepresentation of an investigational device and prolongation of the study are prohibited (§812.7).
•Records and Reports - Sponsors and investigators are required to maintain specified records and make reports to investigators, IRBs, and FDA (§812.140 and §812.150).
