| Title | Date | Formats | |
|---|---|---|---|
| Device Bioresearch Monitoring: Perspectives | 5/25/05 | PPT | Text |
| What’s Happening with Pediatric Medical Devices? | 5/25/05 | PPT | Text |
| CDRH Electronic Submissions Turbo 510(k) for In Vitro Diagnostic Devices | 5/25/05 | PPT | Text |
| Conditions of Approval Studies: the CDRH Perspective | 5/25/05 | PPT | Text |
| Scheduling Pre-Market Inspections | 5/25/05 | PPT | Text |
| HDEs, Humanitarian Use Designations (HUDs), and the Office of Orphan Products | 5/25/05 | PPT | Text |
| Understanding the Pre-IDE Program: FDA Perspective | 5/25/05 | PPT | Text |
| PMA Guidance Updates | 5/24/05 | PPT | Text |
| OIVD Highlights | 5/24/05 | PPT | Text |
| Using the Third Party Review Program | 5/24/05 | PPT | Text |
| What a Great 510(k) Should Look Like | 5/24/05 | PPT | Text |
| Reprocessing of Single Use Devices | 5/24/05 | PPT | Text |
| Turbo 510(k) and Beyond | 5/24/05 | PPT | Text |
| Report from ODE - AdvaMed 15th Annual Device Submission Workshop | 5/24/05 | PPT | Text |
| Critical Path Initiative In Medical Devices - AdvaMed Submissions Workshop | 5/24/05 | PPT | Text |
| CDRH Update 2005 - 8th Annual FDA-OCRA Educational Conference | PPT | Text | |
| Postmarket Surveillance: Medical Devices | 4/8/05 | PPT | Text |
| Early/Expanded Access Provisions for Unapproved/Investigational Medical Devices | 4/8/05 | PPT | Text |
| CDRH Update - Facilitating Medical Device Innovation and Technology | 4/8/05 | PPT | Text |
| New FDA Guidelines for Medical Devices | 4/1/05 | PPT | Text |
| CDRH: A Vision for 2005 and Beyond - MassMEDIC's FDA Update | 12/04 | PPT | Text | |
| Improving the Availability of Pediatric Devices - American Academy of Pediatrics - Washington DC | 6/28/04 | Text | ||
| FDLI Conference: FDA – Regulation of Genomic and Genetic Diagnostic Devices | 4/16/04 | PPT | Text | |
| FDLI Conference: Device Issues | 4/16/04 | PPT | Text | |
| FDLI Conference: The Division of Bioresearch Monitoring Case Studies | 4/16/04 | PPT | Text | |
| FDLI Conference: EPA/FDA Regulatory Partnerships and Partitions | 4/16/04 | PPT | Text | |
| FDLI Conference: Custom Devices | 4/16/04 | PPT | Text | |
| FDLI Conference: Ombudsman | 4/16/04 | PPT | Text | |
| AdvaMed Submissions Workshop - Medical Devices: Innovation
and Regulation |
6/5/03 | PPT | Text | |
| FDA's CLIA Complexity Process | 4/23/02 | PPT | Text | |
| Estimated Benefits of Proposed Amendments to the FDA Radiation-Safety Standard for Diagnostic X-Ray Equipment | 12/31/01 | PPT | Text | |
| Evaluating Breakthrough Technology: An FDA Perspective | 06/15/2001 | PPT | Text | |
| CLIA Update: June 5, 2001 | 06/05/2001 | PPT | ||
| FDA's Final Policy on Single-Use Devices Reprocessed by Hospitals and Commercial Reprocessors | 05/10/2001 05/30/2001 |
PPT | Text | |
| MDMA Presentation - CDRH: Looking Ahead | 05/18/2001 | PPT | ||
| FDLI Presentation: Closing Gaps in Our Postmarket Safety Net for Medical Devices: It’s Everybody’s Business! | 04/18/2001 | PPT | Text | |
| FDLI Presentation: CDRH - Looking Ahead | 04/18/2001 | PPT | ||
| Estimated Benefits of Proposed Amendments to the FDA Radiation-Safety Standard for Diagnostic X-Ray Equipment | 02/15-16/2001 | PPT | Text | |
| Gaps in Your Postmarket Safety Net for Medical Devices | 1/8/2001 | PPT | Text | |
| CDRH Executive Briefing - RAPS Annual Meeting | 10/2000 | PPT | ||
| Device Regulation in an International Milieu | 9/25/2000 | PPT | ||
| Polyvinyl Chloride and DEHP | 9/20/2000 | PPT | ||
| Global Challenges in Human Factors and Medical Systems Mini-symposia | 8/2/2000 | PPT | ||
| CDRH Overview | 7/18/2000 | PPT | ||
| Future Trends | 7/19/2000 | PPT | ||
| Role of the CDRH Ombudsman | 7/2000 | PPT | ||
| The FDA Modernization Act | 6/29/2000 | PPT | ||
| CDRH Update - MDMA | 6/12/2000 | PPT | ||
| AAMI 2000 Conference and Expo | 6/6/2000 | PPT | ||
| CDRH Update - FDLI | 6/5/2000 | PPT | ||
| FDA and the Reuse of Single Use Devices: Policy Moving Forward - FASA Presentation | 5/6/2000 | PPT | ||
| Staff Update: The Least Burdensome Provisions of FDAMA | 4/2/2000 | PPT | ||
| CDRH: Moving Forward | 3/23/2000 | PPT | ||
| The Role of Standards at CDRH | 3/15/2000 | PPT | ||
| Patient Safety: Emerging Opportunities in the Health Care System | 3/2000 | PPT | ||
| Statement By David W. Feigal, M.D. Director, CDRH, Before The Subcommittee On Oversight And Investigations Committee On Commerce U.S. House Of Representatives | 2/10/2000 | Text | ||
| Part 11 News and Views - Electronic Records and Electronic Signatures Regulation | 1/13/2000 | PPT | ||
| CDRH Update | 12/16/1999 | PPT | ||
| The Least Burdensome Provisions of the FDA Modernization Act of 1997 - Training for CDRH Advisory Panels | 12/99 | PPT | ||
| The Least Burdensome Provisions of the FDA Modernization Act of 1997 | 12/13/1999 | PPT | ||
| CDRH Top Priorities 2000 | 12/10/1999 | PPT | ||
| Standards of Evidence for Drug Approvals | 12/9/1999 | PPT | ||
| Assessment of the Quality of Life Impact of Medical Devices | 11/4/1999 | PPT | ||
| Current Issues for Medical Devices | 11/2/1999 | PPT | ||
| Pharmacogenomics: A regulatory perspective | 10/28/1999 | PPT | ||
| Least Burdensome Pathway to Market | 10/25/1999 | PPT | ||
| Protein PK/PD A Regulatory Perspective | 10/19/1999 | PPT | ||
| Current Issues for Medical Devices in the U.S. | 10/12/1999 | PPT | ||
| CDRH Executive Briefing | 10/4/1999 | PPT | ||
| CDRH Update | 9/27/1999 | PPT | ||
| QSIT Corrective and Preventive Actions | various | PPT | ||
| QSIT: Design Controls and Production and Process Controls | various | PPT | ||
| QSIT Management Controls | various | PPT | ||
| The Quality System Inspection Technique: QSIT | various | PPT | ||
| QSIT: Compliance Program and Warning Letter Pilot | various | PPT | ||
| CDRH Directions | 7/27/1999 | PPT | ||
| FDLI Medical Device Update | 6/29/1999 | PPT | ||
| Medical Device User Fees | 5/25/1999 | PPT |
Updated July 21, 2005
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