![TGA Guidance on In-house IVDs: Overview](https://www.regdesk.co/wp-content/uploads/2024/06/TGA-on-in-house-IVDs-overview.jpg)
TGA Guidance on In-house IVDs: Overview
The article highlights the key points related to the regulatory requirements for in vitro diagnostic (IVD) medical devices manufactured by healthcare institutions to address their internal needs.
The article highlights the key points related to the regulatory requirements for in vitro diagnostic (IVD) medical devices manufactured by healthcare institutions to address their internal needs.
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 De Novo Classification requests and the way they impact the FDA review clock and goals. The document...
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the actions related to De Novo classification requests in the context of their effect on FDA review clock...
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document describing De Novo Classification Requests in the context of the effect on the FDA review clock and goals. The...
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document describing in detail the acceptance review for the requests submitted under the De Novo classification process....