To keep up with the advancement of medical technology, the FDA has been working on a digital health pre-certification program that would allow the agency to pre-approve trusted manufacturers to update their software products.

However, this process has encountered some challenges and requires Congressional approval to move forward.

Additionally, the FDA has considered implementing a predetermined change control plan, in which companies can outline expected modifications to software-based devices and make changes within those parameters without having to go through a lengthy submission process with the agency.

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