This article was originally published in The Gray Sheet
Clinical investigations of permanent keratoprostheses (21 CFR 886.3400) require a minimum of 20 patients with follow-up of at least one year, FDA says in a guidance document posted on the agency's website April 26. Any "extraordinary claims will require the calculation of an appropriate sample size sufficient to support the specific claim," according to FDA, which notes that clinical data are not needed for temporary keratoprostheses
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