AdvaMed Accel Regulatory Best Practices Guides
The AdvaMed Accel Regulatory Best Practices Guides are a resource for AdvaMed member companies to gain a better understanding of the FDA regulatory processes and requirements for products regulated by the Center for Devices and Radiological Health (CDRH).
Developed with early-stage manufacturers in mind, the initial guides in this series provide a general overview of premarket and postmarket requirements, investigational device exemptions, presubmission meetings, 510(k) premarket notifications, premarket approvals and de novo requests. These guides will be updated on an ongoing basis with current information. We welcome member feedback – please email [email protected].