![FDA Guidance on Design Validation](https://www.regdesk.co/wp-content/uploads/2021/10/Guidance-on-Design-Validation-1-1080x675.png)
Oct 1, 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 design control in the context of medical devices. Among other matters, the document addresses aspects...
Read More
![FDA on Content of Premarket Submissions For Medical Device Software: Documents in Detail](https://www.regdesk.co/wp-content/uploads/2021/09/fda5-2.jpg)
Sep 20, 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 the content of premarket submissions for software contained in medical devices. The document provides...
Read More
![TGA Guidance on Seasonal Influenza IVD Self-Tests](https://www.regdesk.co/wp-content/uploads/2021/04/australian-flag-2.jpg)
Apr 19, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published guidance dedicated to in vitro diagnostic (IVD) self-tests intended to be used for diagnosing seasonal...
Read More
![FDA Guidance on Medical Device Accessories Classification](https://www.regdesk.co/wp-content/uploads/2021/04/USFDA-2.jpg)
Apr 5, 2021
EU MDR/IVDR
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document detailing how medical device accessories should be described in submissions. The document also provides additional...
Read More
![MDCG Q&A Document on Custom-Made Medical Devices](https://www.regdesk.co/wp-content/uploads/2021/04/EU-1.jpg)
Apr 2, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of the representatives of all Member States, has published a questions and answers document dedicated to custom-made medical devices. The document also describes the...
Read More