![FDA Guidance on Remanufacturing Medical Devices: Requirements](https://www.regdesk.co/wp-content/uploads/2024/06/FDA-on-remanufacturing-medical-devices-considerations-1.jpg)
Jun 26, 2024
FDA
The new article elaborates further on the requirements to be fulfilled by the entities involved in the activity considered remanufacturing based on considerations described in the previous article.
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![FDA Guidance on De Novo Classification Process](https://www.regdesk.co/wp-content/uploads/2021/10/Guidance-on-De-Novo-Classification-Process-1080x675.png)
Oct 15, 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 De Novo classification process and regulatory framework associated thereto. Table of Contents Due...
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![FDA Guidance on Infusion Pumps: Specific Aspects](https://www.regdesk.co/wp-content/uploads/2021/10/us-medical-1080x675.jpg)
Oct 14, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document on infusion pumps. Table of Contents The document addresses the most important...
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![FDA Guidance on Infusion Pumps: Performance Testing](https://www.regdesk.co/wp-content/uploads/2021/09/Guidance-on-Infusion-Pumps-Performance-Testing-1080x675.png)
Sep 30, 2021
FDA
The Food and Drugs Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to infusion pumps. The guidance highlights matters related to performance testing. It is important to...
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![TGA Guidance on Medical Software](https://www.regdesk.co/wp-content/uploads/2021/08/TGA-Guidance-on-Medical-Software-1-1080x675.png)
Aug 20, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority responsible for medical device regulations, has published detailed guidelines describing how one can determine whether software falls within the scope of medical device regulatory...
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