The US Food and Drug Administration (FDA) has released draft wording for a new rule that would allow gretaer use of electronic instructions for use for many types of medical device. The proposed rule, if finalized, would clarify that the “adequate directions for use” requirement under section 502(f) of the Federal Food, Drug, and Cosmetic…

The US Food and Drug Administration has recently published a Q&A document on the subject of Clinical Support Software, following release of full guidance on the topic in January 2026. The Q&A explains that “Clinical Decision Support (CDS) software are important tools in modern health care. While some CDS software has been excluded from the…

Two delegated acts on well-established technologies (WET) under the Medical Device Regulation (MDR, 2017/745) have now been published in the Official Journal of the EU. Well-established technologies are relatively simple devices, with common and stable designs that don’t evolve significantly, have well-known safety and clinical performance characteristics, with a long history on the market. The…

The US Food and Drug Administration (FDA) maintains publically available lists of safe and effective medical devices, including devices that incorporate digital health technology. The Agency has recently updated its searchable lists of such devices, including Artificial intelligence (AI) Augmented reality and virtual reality Sensor-based digital health technology The FDA lists are not comprehensive resources…

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced its intention to move towards full membership of the Medical Device Single Audit Program (MDSAP), the international scheme that allows a single quality management system audit to satisfy the regulatory requirements of multiple participating regulatory agncies. At present, MHRA is an official observer of…