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Presentation: FDLI Conference, Washington DC
April 16, 2004

PowerPoint Slides

Device Issues

Christine Nelson
United States Food and Drug
Administration
Center for Devices and Radiological
Health

April 16, 2004
FDLI 47^th Annual Conference

Agenda

1. Global Harmonization Task Force
2. Mutual Recognition Agreement (MRA)
3. AP Program (International aspects)

1. Global Harmonization Task Force (GHTF)

GHTF Goals

• To harmonize regulation of medical devices among members
• To provide model for medical device regulation for other countries

GHTF Members

Regulatory authorities and industry from:

• Australia
• Canada
• European Union
• Australia
• United States (U.S.)

Recent Final GHTF Guidance

Study Group 2 (SG 2) – Post Market Vigilance / Surveillance

• Reporting of Use Errors with Medical Devices
• Universal Data Set for Manufacturer Adverse Event Reports

Recent Final GHTF Guidance

SG 3 – Quality Systems

• Process Validation, Ed. 2

Recent Proposed Guidance

SG 1 – Premarket

• Essential Principles of Safety and Performance of Medical Devices (including In Vitro Diagnostic Devices)

Recent Proposed Guidance

SG 1 – Premarket

• Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)

Recent Proposed Guidance

SG 1 – Premarket

• Principles of Medical Devices Classification
• Definition of "Medical Device"

Recent Proposed Guidance

SG 1 – Premarket

• Role of Standards in the Assessment of Medical Devices (including In Vitro Diagnostic Devices)

Recent Proposed Guidance

SG 4 – Auditing

• Regulatory Auditing Strategy

2. Mutual Recognition Agreement (MRA) with the European Commission (EC)

MRA Device Activities

1. Premarket product review and/or testing
2. Inspections/audits
3. Exchange of vigilance reports

Status of European Union (EU) Conformity Assessment Bodies (CABs)

• Seven EU CABs meet FDA criteria
• Four EU CABs can conduct independent inspections

Status of U.S. CABs

• Six U.S. CABs meet EU criteria
• Work to be done

• On-site audits
• Observe U.S. CABs audit manufacturers

3. Accredited Persons (AP) Inspection Program: International Aspect

International Aspect

• All APs are, are affiliated with, or have a working relationship with foreign CABs
• Eight APs are or are affiliated with EU CABs under MRA

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Updated July 8, 2004

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