GMP News - Medical Devices

In October 2022, the Center for Devices and Radiological Health (CDRH) published a list of new guidances planned for fiscal year 2023 (1 October 2022 - 30 September 2023), as well as older guidances to be reviewed for topicality. What is planned?

The ECA regularly analyses the deficiencies identified in FDA Warning Letters relating to medical devices. Since medical devices can also be part of a combination product of a medicinal product and a medical device, these statistics are also of interest to manufacturers of these products. What do the medical device Warning Letter statistics show for the 2022 fiscal year?

You could already read in the past about the FDA CDRH's website for medical devices. It provides you with the possibility to get familiar quickly with the topic "medical devices" or to stay up to date. What is new?

The FDA published now a guidance document on Instructions for Use (IFU) labeling. What is the recommended font and font size?

With UK's exit from the EU (Brexit), a transition period also started with regard to medical devices. The MHRA has now published plans on how to proceed after this transition period.

The FDA provides recommendations for sponsors, investigators, and other interested parties on the use of digital health technology for remote data acquisition in clinical trials. What is required regarding software validation and electronic documents?