Resource Center

An up-to-date, comprehensive list and online access to relevant files and presentations

510(k) Basics
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).

Case Studies
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)

International Regulations
Links pertaining to the Medical Device regulatory process in Europe, Canada, Australia, Japan and China.