FDA, Government & Medical Devices
CDRH - Overview
CDRH Internal Evaluations
Press Release: FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making
FDA Discussion on the Draft 510(k) and Use of Science in Regulatory Decision Making Reports (Audio Playback)
CDRH Plan of Action for 510(k) and Science: Implementation of Recommendations from the 510(k) and Science Reports
Plan of Action for Implementation of 510(k) and Science Recommendations (pdf)
Federal Register Docket No. FDA-2010-N-0348
Comments (9 parts as pdfs, merge all after downloading) Part 1, Part 2, Part 3, Part 4, Part 5, Part 6, Part 7, Part 8, Part 9
CDRH Preliminary Internal Evaluations
Announcements, News and Events
FDA to improve most common review path for medical devices Jan 19, 2011
Impact of Medical Device Regulation on Jobs and Patients, J. Shuren, before Subcommittee on Health, Feb 17, 2011 (also on FDA website)
CHI Competitiveness and Regulation: The FDA and the Future of America's Biomedical Industry Feb, 2011 (pdf), Fact Sheet (pdf)
FDA's Role in Fostering the Development of Better Medical Devices
Initial results of 510(k) Audit - Analysis of Not Substantially Equivalent (NSE) Determinations, June 15, 2011 (pdf)
FDA to seek public comment on IOM recommendations, July 29, 2011
Strategic Planning
Fiscal Year 2010, Strategic Priorities - Accomplishments
Fiscal Year 2010, Strategic Priorities
CDRH 2011 Strategic Priorities
Transparency
Evaluation of Automatic Class III Designation (De Novo) Decision Summaries, November 2010
Overview of Medical Devices and Their Regulatory Pathways
Adverse Event Flowchart (pdf)
Procedures
SOP: Management of Review Staff Changes During the Review of a Premarket Submission
Draft Guidance for Industry and Food and Drug
Administration Staff - The 510(k) Program: Evaluating Substantial
Equivalence in Premarket Notifications [510(k)]
Understanding Barriers to Medical Device Quality (pdf)
FDA Regulation of Medical Devices, December 28, 2011, Congressional Brief (pdf)
Databases and Networks
510(k) Premarket Notification Database Search
MAUDE (Manufacturer and User Facility Device Experience) Database Search
News (Medical Devices)
Medical & Radiation Emitting Device Recalls Database
MedSun: Medical Product Safety Network
FDA-TRACK: Agency-wide Program Performance
Annual Reports (covers CDRH goals for each year)
Fiscal Year 2005 (pdf)
Fiscal Year 2004 (pdf)
Fiscal Year 2003 (pdf)
Fiscal Year 2000 (pdf)
Ombudsman Annual Reports (covers statistics for CDRH for each year)
Calendar Year 2008
Calendar Year 2007
Calendar Year 2006
Calendar Year 2005
Calendar Year 2004
Calendar Year 2003
Calendar Year 2001
Medical Device Technology Forecast
Office of Device Evaluation (ODE)
Annual Performance Reports
Fiscal Year 2008 (pdf)
Fiscal Year 2007 and 2006 ODE Annual Report (pdf)
Fiscal Year 2005 (pdf)
Fiscal Year 2004 (pdf)
Fiscal Year 2003 ODE/OIVD Annual Report (pdf)
Fiscal Year 2002 (pdf)
Fiscal Year 2001 (pdf)
Fiscal Year 2000 (pdf)
Office of In Vitro Diagnostic Devices (OIVD)
Evaluation and Safety Annual Reports (covers advances and key performance indices)
Fiscal Year 2005 (pdf)
Fiscal Year 2003 (ODE/OIVD) (pdf)
US House of Representatives: Committee on Energy and Commerce
Hearings on Subcommittee on Health, June 18, 2009
Medical Devices: Are Current Regulations Doing Enough for Patients?
Impact of Medical Device Regulation on Jobs and Patients, Feb 17, 2011
Background Memo (pdf)
Archived Webcast (wvx)
Opening Statements: Health Subcommittee Chairman, Joe Pitts and Commerce Committee Chairman Fred Upton
Written Testimony: Jeffrey E. Shuren, M.D., J.D. (written testimony) (pdf)
Written Testimony: Josh Makower, M.D. (written testimony) (pdf)
Written Testimony: Mark Deem (written testimony) (pdf)
Written Testimony: Ralph F. Hall (written testimony) (pdf)
Written Testimony: Dr. Rita Redberg (written testimony) (pdf)
Written Testimony: Dr. Steven E. Nissen (written testimony) (pdf)
US Senate: Special Committee on Aging
A Delicate Balance: FDA and the Reform of the Medical Device Approval Process, April 13, 2011
Hearings - FDA's Medical device Review Scrutinized at Senate Hearing, April 13, 2011
Flash Video Image of Senate hearing
Medical Device Recalls and the FDA Approval Process, Referenced paper by Diane Zuckerman, 2011 (pdf)
Panel Statement - Katie Korgaokar (pdf)
Panel Statement - Marcia Crosse (pdf)
Panel Statement - Diana Zuckerman (pdf)
Panel Statement - Frederic Resnic (pdf)
Panel Statement - Ralph Hall (pdf)
Panel Statement - David Nexon (pdf)
Panel Statement - William Maisel (pdf)
United States Government Accountability Office (GAO)
Reports
Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process, Jan 2009 (Publication No. GAO-09-190) (pdf)
Shortcomings in FDA’s Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments, Marcia Crosse June 18, 2009 (pdf)
Medical Devices: FDA's 510(k) Operations Could be Improved, August 1988 (pdf)
Other Medical Device Information
Healthcare Providers (Medical Devices)
FDA Patient Safety News (Video)
Public Health Notifications
CLIA - Clinical Laboratory Improvement Amendments