FDA deals warning letter to Ocular over eye sealant

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.
Get the full story at our sister site, Drug Delivery Business News.
The post FDA deals warning letter to Ocular over eye sealant appeared first on MassDevice.

Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Featured Food & Drug Administration (FDA) Optical/Ophthalmic Regulatory/Compliance Wall Street Beat Wound Care oculartherapeutix Source Type: news