The FDA rapped six U.S. devicemakers for numerous GMP and quality deficiencies found during inspections of their facilities. Source: The GMP Letter

U.S. lawmakers are considering a bipartisan bill that would give the FDA authority to destroy counterfeit medical devices. Source: The GMP Letter

Time is running out for devicemakers to meet the May 26 deadline to renew or extend their device certificates under the new EU Medical Devices Regulation, MedTech Europe stressed in…

The FDA hit Draeger Medical Systems with a warning letter for failing to submit a new 510(k) premarket notification for “significant changes” it made to its patient monitoring device. Source:…

Some devicemakers will be allowed to continue placing their products on the EU market while they deal with the unexpected withdrawal of a notified body, the UK’s Medicines and Healthcare…

The FDA has released new details of its pilot accreditation scheme for medical device conformity assessments that it expects to launch later this year. Source: The GMP Letter

The FDA cited six devicemakers for a range of GMP and other failures, including root-cause analysis for nonconforming products and lax environmental controls. Source: The GMP Letter

The FDA released draft guidance for devicemakers on 510(k) submissions for catheter-based devices intended to treat peripheral vasculature lesions, including suggestions on labeling and performance testing. Source: The GMP Letter

The FDA slapped Henan Kangdi Medical Devices with a warning letter over repeat CGMP failures at its Zhoukou, Henan facility, including a lack of testing. Source: The GMP Letter

The EU’s Medical Device Coordination Group released new guidance on cybersecurity requirements for devicemakers under the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Source: The GMP…