Ocular Therapeutix (NSDQ:OCUL) said today that it received a warning letter from the FDA over its ReSure hydrogel ocular wound sealant.
The warning letter, dated Oct. 17, relates to Ocular’s compliance with data collection and reporting obligations in a post-approval device exposure registry study, according to the company. The registry study was a condition for approval of the premarket approval application for Ocular’s ReSure product.
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