The GMP Letter

The Office of Management and Budget has approved the FDA’s long-awaited proposed rule on a unique device identifier (UDI), clearing it for release by the agency.

The EU is one step closer to mandating premarket authorization for Class IIb and Class III medical devices, following the European Parliament’s adoption of proposals aimed at beefing up device regulation in the wake of the PIP silicone gel breast implant scandal.

Sunrise Medical’s GMP slips related to one of its wheelchairs led to two of five observations on a Form 483 issued for a Jan. 11-19 inspection.

Failure to report adverse events from a battery-operated toothbrush were among several observations in a Form 483 generated after a Jan. 9 to Feb. 13 inspection of Church & Dwight’s Princeton, N.J., facility.

A Form 483 for AngioDynamics of Queensbury, N.Y., states the company distributed a range of devices with flaws or unapproved features.

Siemens Healthcare Diagnostics has received its second FDA warning letter this summer, following an inspection of the company’s Newark, Del., plant.

Healthcare regulatory affairs professionals in North America saw their salaries and bonus levels rise by an average of 3 percent in 2011, making modest but notable compensatory gains during a year punctuated by economic malaise, according to a new biennial survey from the Regulatory Affairs Professionals Society (RAPS).

The House has passed H.R. 4223, the SAFE Doses Act, by voice vote, taking another step toward ramped-up penalties for medical product thefts.

European medical devicemakers will be required to use a new labeling standard that reduces the need for multiple languages on a single label and improves potential confusion and delays for selecting the appropriate language when using a device.

An optical supplies manufacturer has received an FDA warning letter for nine violations, most relating to complaint handling, device design and process control procedures.