Product Overview
Submissions
FDA Regulatory Pathways and Submission Types
Some of the pathways to market you may not have heard much about.
Special 510(K)
Traditional 510(k)
Abbreviated 510(k)
PMA and PMA supplements
HDE/HUD
De Novo
Combination Product – Read more in SPECIALTY SERVICES
Investigational Device studies may be required to support any of these pathways. We provide services to assure they are conducted properly when needed.
A submission may be needed when there is a change to a device that is already 510(k) cleared. We can help you assess the changes and prepare a submission if required.
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Submissions
