The FDA cited six devicemakers for a variety of quality problems uncovered during the agency’s inspections of their facilities. Source: The GMP Letter

The FDA is introducing a new review program for certain medical devices and device-led combination products that are expected to significantly improve the safety of treatments for a disease or…

The FDA is establishing a pilot accreditation scheme for conformity assessment (ASCA) whereby testing laboratories may be accredited by accreditation bodies to assess the conformance of a device within certain…

The European Commission released final guidelines for devicemakers, notified bodies and regulators on how to perform a benefit-risk analysis for phthalates in medical devices. Source: The GMP Letter

An FDAnews analysis of the FDA’s Form 483 inspection reports for fiscal year 2019 shows devicemakers continue to be tripped up at the same old hurdles. Source: The GMP Letter

China’s National Medical Products Administration is gearing up to implement a unique device identification system and it has created a pilot program that will focus on high-risk implantable devices first.…

The FDA cited six devicemakers for problems with complaint procedures, change controls and quality oversight, among other deficiencies. Source: The GMP Letter

The FDA issued a warning letter to Polymer Technology Systems — doing business as PTS Diagnostics — arising from an inspection earlier this year of its facility in Indianapolis. Source:…

The FDA is making new recommendations to manufacturers of duodenoscopes to transition to new designs that will eliminate the need for reprocessing. Source: The GMP Letter

Russia’s Ministry of Health has rolled out new requirements for internal quality control and monitoring of the safety of devices in medical facilities. Source: The GMP Letter