The European Union’s new Medical Device Regulation (MDR) will create significant compliance headaches for manufacturers — including new harmonized standards, classification rules, and conformity assessment procedures. Source: The GMP Letter

The FDA has issued marketing approval for the first direct-to-consumer genetic tests to assess inherited risks for 10 diseases. Source: The GMP Letter

The FDA’s device center has tripled the number of staff with quality credentials to conduct on-site quality training and inspections. Source: The GMP Letter

Inovar received a Form 483 for failing to provide a product certification, evaluate complaints, and other observations. Source: The GMP Letter

Flotec was hit with a Form 483 for inadequate reviews of nonconforming products, poorly documented corrective action procedures, and inadequate complaint reviews. Source: The GMP Letter

India has finalized new regulations that separate out devices for the first time from broader drug regulations. Source: The GMP Letter

Germany’s Biotronik received a warning letter for inadequate process validation procedures, supplier selection procedures, and other violations. Source: The GMP Letter

Korea-based Neo Vision received a warning letter for failing to establish proper design controls, monitor production processes, maintain device history records, and other violations. Source: The GMP Letter

Heater cooler units used in cardiopulmonary bypass and extracorporeal membrane oxygenation can generate potentially infectious aerosols containing a range of harmful bacteria, some of which can be fatal, according to…

The FDA slapped medical device manufacturer XZeal Technologies with a Form 483, citing issues with reporting procedures and design validation. Source: The GMP Letter