Considering the large number of IOL studies, how does an IRB approach the review of a new IOL style?
Full IRB review is required for all new IOLs that exhibit major departures from available lenses. Minor changes to existing lenses may be approved through expedited review. FDA designates new IOL styles as either major or minor changes based upon a predetermined classification scheme and advises the sponsor of its determination. The sponsor, through the investigator, should provide the IRB with the investigational plan which indicates the FDA study requirements, as well as the informed consent document and other comparative information on the proposed lens that describes its characteristics. It is the IRB’s prerogative to request any relevant information on a new IOL to arrive at a decision or to be more rigorous in its evaluation than FDA considers minimally required.
Related Questions
- When should an Institutional Review Board (IRB) or institution request a "407" review for research involving children as subjects?
- How can I be sure that the Style Coach™ I am considering working with has received the proper training and is legitimate?
- Considering the large number of IOL studies, how does an IRB approach the review of a new IOL style?
