FDA, Government & Medical Devices

CDRH - Overview

CDRH Internal Evaluations

CDRH recommendations, 510(k) Report, Oct 7, 2010 (pdf)
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 (on website)
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 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Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]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)

Office of Device Evaluation (ODE)

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)

Industry (Medical Devices)