Getting closer to the 30 day mark for IDE submission.
Upon receipt of an IDE application, sponsors are notified via email of the date that FDA received the original application and the IDE number assigned. An IDE application is considered approved 30 days after it has been received by the FDA, unless the FDA otherwise informs the sponsor via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved. In cases of disapproval, a sponsor has the opportunity to respond to the deficiencies and/or to request a regulatory hearing under 21 CFR Part 16.
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).
