FDA Draft Guidance on Regulatory Flexibility for Class B, C and D Medical Devices
The article highlights the critical points of the regulatory approach concerning specific medical devices intended to be marketed and used in the Philippines.
The article highlights the critical points of the regulatory approach concerning specific medical devices intended to be marketed and used in the Philippines.
The new article highlights the aspects related to the applicability scope, and also provides definitions of the key terms and concepts.
The article highlights the aspects related to the key considerations for methodologies used in the context of the collection and analysis of real-world evidence.
The new article highlights the aspects of the documentation the authority expects to be submitted for review.
The new article highlights the aspects related to how the regulatory context should be considered when assessing real-world evidence and real-world data.