Resource CenterAn up-to-date, comprehensive list and online access to relevant files and presentations
Information from FDA and other sources basic to the 510(k) regulatory process
FDA, Government and Medical Devices
Documents from FDA branches (CDRH, ODE and OIVD), Medical Device User Fee and Modernization Act (MDUFMA) and US House of Representatives: Committee on Energy and Commerce
FDA Guidance Documents
Definitions, Overview and general guidance documents relating to the 510(k) regulatory process
Workshops and Conferences
Listing of Webinars, TownHall and Public meetings, Public Workshops and Conferences pertaining to 510(k).
FDA Training and Continuing Education Courses
Links to video presentations and slide presentations relating to 510(k)
Medical Device Associations
Information from Medical Device associations pertaining to the 510(k) regulatory process and reactions to changes
Institute of Medicine of the National Academies (IOM)
Links to agendas, webcast, presentations and reports from Meetings 1, 2 and 3 relating to 510(k).
As they are identified, case studies that illustrate aspects of the 510(k) regulatory process will be presented
A list of identified articles pertaining to 510(k)
Commonly used abbreviations associated with the FDA and 510(k)
Links pertaining to the Medical Device regulatory process in Europe, Canada, Australia, Japan and China.