CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Source: The GMP Letter

The FDA flagged almost a dozen devicemakers for noncompliances observed during agency inspections, including inadequate medical device reporting. Source: The GMP Letter

The FDA warned three devicemakers in Germany, The Netherlands and the U.S. for GMP and other violations, including inadequate responses to a Form 483 report. Source: The GMP Letter

The FDA recommended the addition of a contraindication for the use of certain ultrasonic surgical aspirator devices for removing uterine fibroids. Source: The GMP Letter

The FDA has classified genetic health risk assessment systems as Class II with special controls, and is proposing to exempt the devices from premarket reviews. Source: The GMP Letter

The FDA released final recommendations for manufacturers of x-ray imaging devices aimed at clarifying the premarket review process and encouraging pediatric indications. Source: The GMP Letter

Devicemakers were mostly supportive of the Therapeutic Goods Administration’s plan to strengthen sanctions and penalties in Australia so it could respond better to repeated non-compliance. Source: The GMP Letter

The FDA has finalized a more detailed “leapfrog guidance” on additive manufactured, or 3D-printed, medical technologies outlining some of its initial thoughts on technical considerations. Source: The GMP Letter

The FDA released final guidance on requirements for direct marking of devices with unique device identifiers. The final document closely resembles the draft version issued in June 2015. Source: The…

Royal Philips agreed to enter into a consent decree with the U.S. Department of Justice to suspend production of its automated external defibrillators at two of its U.S. manufacturing sites.…