![FDA Guidance on eCopy Program for Medical Device Submissions](https://www.regdesk.co/wp-content/uploads/2021/04/FDA-Social-Graphic-1080x675.png)
Apr 7, 2021
FDA
The Food and Drugs Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the eCopy Program for medical device submission. The present document constitutes an updated version of...
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![FDA Guidance on Benefit-Risk Factors in Premarket Notifications (510(k))](https://www.regdesk.co/wp-content/uploads/2021/04/FDA.jpg)
Apr 1, 2021
FDA
The Food and Drug Administration (FDA) has developed a guidance document dedicated to the benefit-risk factors to be considered when determining substantial equivalence in premarket notifications (510(k)) with different technological characteristics. The document is...
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![AEMPS Applies for NB Designation](https://www.regdesk.co/wp-content/uploads/2019/07/spain-flag-800x675.jpg)
Jul 9, 2019
EU MDR/IVDR
According to the MDR requirements, Notified Bodies (NB) should be designated to maintain operations connected with the registration process and perform other supervisory actions. In the course of these medical device regulations, the Spanish regulating authority, the...
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![The EMA Published Draft Guidance on DDC Products.](https://www.regdesk.co/wp-content/uploads/2019/06/ema-1080x675.jpg)
Jun 4, 2019
Europe
European Medicines Agency issued a new draft guidance related to drug-device combinations. This particular regulation specifies the necessary documents for the application for marketing authorization for these types of devices. This particular regulation specifies the...
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