Jun 16, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to cybersecurity aspects related to medical devices containing off-the-shelf (OTS) Software. Due to the...
Read More
Jun 14, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority responsible for healthcare products, has published a guidance document dedicated to off-the-shelf software use in medical devices. The latest version of the document was issued in...
Read More
Jun 11, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published guidance dedicated to the content of premarket submissions for the software contained in medical devices. The latest version of the...
Read More
May 28, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document describing how a responsible entity can determine whether a software change to a medical device already placed on the...
Read More
Apr 28, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published detailed guidelines dedicated to clinical decision support software (CDSS). The document describes general regulatory requirements,...
Read More