Category: FDA Updates

FDA Updates

FDA Gets Over 21,000 Medical Device Reports, Including 124 Deaths, Linked to Philips Foam Breakdown

The FDA updated a safety communication regarding medical device reports associated with the breakdown of materials used in Philips devices.

FDA Updates

FDA Proposes Order Forcing Philips to Repair, Replace or Refund All Recalled Ventilators

The FDA is proposing an order be issued that would require Philips Respironics to address recalled devices, including millions of ventilators.

FDA Updates

Philips Piles on Another Trio of Class I Recalls for Beleaguered Ventilator Portfolio

Philips is facing another string of recalls in its portfolio, which have a received a Class I rating, the most serious type of recall.

Clearances

FDA Clears Lazurite’s Wireless Camera for Minimally Invasive Surgery

The U.S. FDA has granted market clearance for Lazurite’s ArthroFree wireless camera system for minimally invasive surgery.

Recalls

Thousands of Ventilators Pulled as Electrical Faults Put UK Patients’ Lives at Risk

Amid an ongoing current of medical product recalls, hospitals in the United Kingdom are experiencing new electrical problems with certain Philips ventilators.

Labeling

Ready for the UDI Enforcement Deadline?

If your company produces medical or health-related products, you need to know whether they meet the FDA’s definition of Class I medical devices—and, if so, you need to start now to implement UDI Rule requirements before enforcement begins on September 24.

Draft Guidances

FDA Issues Draft Guidance on Remanufacturing, Seeks Feedback on Cybersecurity Servicing of Medical Devices

The U.S. FDA is now accepting comments from the public on the draft guidance, “Remanufacturing of Medical Devices,” and on a discussion paper on cybersecurity servicing of devices.

If you want to play the latest, biggest, or best New Zealand casinos, then the best option for you is to play on the Internet. New Zealand has some of the most amazing online casinos available. However, if you are looking for one of the most popular real money online casinos, look no further than Radisson Sevens. This is one of the best New Zealand casinos that offers you exciting casino games, great bonuses and promotions, and a variety of ways to win. Plus, if you want to learn more about card games, then you will surely love this website!