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Comparing the FDA 510(k) and De Novo Device Pathways
Check out the similarities and differences of two different paths (510(k) and De Novo) for getting pre-marketing authorization from the FDA for a software-as-a-medical-device.
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The FDA Are People, Too.
Government agencies seem like monolithic entities governed by complex rules that are hard to relate to. Still, under that seemingly impenetrable exterior, it helps to remember that, just like your startup, the agency is made up of people, too.
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Effectively Engaging the FDA
Some vital resources and lessons learned along our software-as-a-medical device FDA journey may help others who are finding their own pathways to market with a regulated product. While these ideas are focused on the FDA, they have broader applicability to working with other regulatory bodies as well.
