Timeline for approval depends first on the risk then......https://www.fda.gov/medical-devices/investiga...al-process
Just food for thought but assuming the Hemostyp CelluSTAT gauze is a "Significant Risk Device" as the FDA protocol for review states then...
NAMSA must "In order to conduct a significant risk device study, a sponsor must:"
Submit a complete IDE application (§812.20) to FDA for review and obtain FDA approval of the IDE;
submit the investigational plan and report of prior investigations (§812.25 and §812.27) to the IRB at each institution where the investigation is to be conducted for review and approval; and select qualified investigators, provide them with all necessary information on the investigational plan and report of prior investigations, and obtain signed investigator agreements from them.
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.
GO NAMSA you got the ball baby!
Just food for thought but assuming the Hemostyp CelluSTAT gauze is a "Significant Risk Device" as the FDA protocol for review states then...
NAMSA must "In order to conduct a significant risk device study, a sponsor must:"
Submit a complete IDE application (§812.20) to FDA for review and obtain FDA approval of the IDE;
submit the investigational plan and report of prior investigations (§812.25 and §812.27) to the IRB at each institution where the investigation is to be conducted for review and approval; and select qualified investigators, provide them with all necessary information on the investigational plan and report of prior investigations, and obtain signed investigator agreements from them.
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.
GO NAMSA you got the ball baby!
