We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA will hold a March 5 public workshop on evaluation practices for virtual and augmented reality in medicine at the agency’s White Oak Campus in Silver Spring, Maryland. Read More
Time is running out for devicemakers to meet the May 26 deadline to renew or extend their device certificates under the new EU Medical Devices Regulation, MedTech Europe stressed in its latest status report. Read More
Taiwan’s legislature passed the Medical Device Management Law, which separates the country’s regulation of medical devices from pharmaceutical products for the first time. Read More
China’s National Medical Products Administration (NMPA) updated its clinical trial regulations for medical devices last month, designating eight device categories that require clinical trials. It also added new exemptions from clinical trial requirements, allowed conditional approval with limited clinical data and published guidelines on the use of real-world data (RWD). Read More
The EU’s Medical Device Coordination Group released new guidance on cybersecurity requirements for devicemakers under the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Read More
The FDA has released a new draft guidance that lays out a step-by-step process for applying data from a previously approved delivery system, a practice commonly known as bridging, to an application for a combination product. Read More
An FDA inspection of Medical Informatics’ Houston, Texas facility revealed lax complaint handling and a lack of medical device reporting procedures.
Read More
Westwood Laboratories didn’t establish corrective and preventive action procedures for nonconforming products, according to a 483 received following an inspection of the firm’s Azusa, California plant.
Read More
Algomedica’s Sunnyvale, California facility drew a Form 483 when an inspection revealed a pattern of failing to address root causes of nonconformance of its artificial intelligence algorithm PixelShine that analyzes CT scans. Read More
The FDA slapped Henan Kangdi Medical Devices with a warning letter over repeat CGMP failures at its Zhoukou, Henan facility, including a lack of testing.
Read More