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Even as more and more healthcare is moving into the home, manufacturers and other stakeholders remain ill-prepared to serve that patient population. Read More
A recent appeals court hearing on the Securities and Exchange Commission’s conflict minerals disclosure rule provided no immediate relief for manufacturers — though the line of questioning suggested some judges were sympathetic to industry’s free speech argument against the rule. Read More
China’s National Health and Family Planning Commission announced “severe” new measures aimed at barring device- and drugmakers convicted of bribery from selling their products in the domestic market — for as long as four years in some cases. Read More
As 2013 wound down, lawmakers in Japan pushed through drug overhaul legislation, paving the way for a distinct regulatory regime for medical devices and raising industry hopes that long-awaited device regulations won’t be far behind. Read More
Synecco, a China-based contract manufacturer and contract sterilizer, received an FDA warning letter for shortfalls in sterilization validation and other GMP issues. Read More
San Up, a Buenos Aires maker of piston and ultrasonic nebulizers, was warned by the FDA after cleaning shortfalls and other good manufacturing practice slip-ups. Read More
At the close of a comment period on the quality management systems reporting burden for devicemakers, the FDA received just one reply requesting a few clarifications. Read More
CAPA shortfalls identified during an FDA inspection in late August and September led to a recent Form 483 for Teleflex Medical. Among noted deviations, the company did not evaluate whether it should initiate a CAPA for distributed humidifier adaptor devices with seal defects. Read More
Lucero Medical, maker of the Enduramesh Corpectomy Spacer System, lacks design validation for the device, despite implantation of 89 of the vertebral body replacement systems by the time of an FDA inspection, according to a recent Form 483. Read More
Last year was a key year for advancements in device supply chain transparency, with the FDA’s September release of its final unique device identification rule. Read More
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