•   Lean Start-Up Panel Slide Show (PowerPoint document)

•   510(k) Decision Tree (pdf)

•   510(k) vs. PMA Regulatory Strategies Differences Table

•   A guide to the FDA's draft guidance on 510(k)s (pdf)

•   American College of Surgeons Surgery News IOM Recommends Replacing the 510(k) Device Process (pdf)

•   California Health Institute on Clearance Processes (pdf)

•   Congress Questions 510(k) Regulatory Changes Medical Device News and Insights Blog (pdf)

•   Device Approvals and Clearances (pdf)

•   FDA Announces Changes To Medical Device 510(k) Approval Process Medical Device News and Insights Blog (pdf)

•   FDA Rules Medical Devices (pdfpdf)

•   FDA Transparency and the Consequences for Medical Device Companies Medical Device News-and Insights Blog (pdf)

•   Medical Device or Drug Negotiating with the FDA (pdf)

•   Medical Device User Fee and Modernization Act Documents the Center for Devices and Radiological Health is Considering for Development (FY12) (pdf)

•   New 510(k) Guidance TheHeart.org •   (pdf)

•   PMAs 510(k)s and Advanced IDE Topics (pdf)

•   Premarket Clearance Changes 510(k) Update Medical Device News and Insights Blog (pdf)

•   Premarket Notification 510(k) (pdf)

•   Press Announcements FDA Issues Assessments of the 510(k) Program and Use of Science in Decision Making (pdf)

•   Press Announcements FDA to Improve Most Common Review Path For Medical Devices (pdf)

•   Safety Assurance Cases and Medical Device 510(k) Submissions Medical Device News and Insights Blog (pdf)

•   Small Company Perspective 510(k) vs. PMA Avenue to Market (pdf)

•   Smaller Medical Device Companies Facing Extended 510(k) Review Periods Medical Device News and Insights Blog (pdf)

•   What are 510(k) Clearance and Premarket Approval? (pdf)