FDA Warns BD Over Changes Made to Blood Collection Tubes in Lead Testing Investigation
By Michael Mezher -
Published 12 January 2018
After launching an investigation into the root cause of false lead test results from four of Magellan Diagnostics' LeadCare testing systems last May, the US Food and Drug Administration (FDA) on Thursday warned Becton Dickinson (BD) for failing to submit a new 510(k) for changes to its blood collection tubes.
Categories: News, FDA, In vitro diagnostics, Medical Devices
Tags: BD, LeadCare, Magellan Diagnostics, Vacutainer, Warning Letter
BD, Roche Weigh FDA’s Proposed Exemptions for Class II Devices
By Zachary Brennan -
Published 15 May 2017
Beckton, Dickinson and Co. (BD) and Roche Diagnostics are seeking clarifications and changes to the US Food and Drug Administration’s (FDA) proposed list of Class II medical devices to be exempted from premarket notification.
Categories: News, US, CDRH, Business and Leadership, Medical Devices, Regulatory intelligence, Regulatory strategy
Tags: Roche Diagnostics, BD, Class II exemptions, 21st Century Cures Act