FDA Warns California Device Company for Failing to Disclose Serious Injury
By Zachary Brennan -
Published 05 December 2017
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last month to Sacramento, California-based Hand Biomechanics Lab after the firm failed to submit a report to the agency of a serious injury that may have been caused by one of the company’s medical devices.
Categories: News, US, CDRH, Compliance, Medical Devices
Tags: warning letter, device injury