MDA Guidance on Advertisement Approval: Application Details
The article highlights the aspects related to the information to be included in the application an interested party should submit.
The article highlights the aspects related to the information to be included in the application an interested party should submit.
The article highlights the aspects related to the life cycle of the digital health applications included in the respective directory.
The article highlights the aspects related to the first two methods of selecting predicates: for medical devices that are cleared based on well-established methods, and also for the products that meet or exceed the expectations.
The new article addresses the aspects related to the data security measures to be introduced by the parties involved in operations with digital health products.
The article describes the basics of the approach the applicants should follow when selecting a predicate device to demonstrate substantial equivalence.