Biomedical Engineering Committee

The Biomedical Engineering Committee serves as a resource to the AAOS fellowship and the public for scientific and regulatory developments in the field of biomedical engineering as they relate to orthopaedic surgery, practice, and patient care. The Biomedical Engineering Committee collaborates with regulatory bodies, governmental and standard-setting agencies, the orthopaedic industry, and the medical community to advocate for the development and availability of safe and effective orthopaedic medical devices.

Position and Information Statements

• Consensus Standards for Medical Devices
• Implant Device Recalls
• Pharmaceutical and Device Company Direct to Consumer Advertising

Comments and Activities (All in PDF format)

• Adverse Event Reporting - Improving Human Subject Protection
• Draft Guidance on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
• Strengthening the Center for Device and Radiological Health’s 510(k) Review Process
• Center for Devices and Radiological Health 510(k) Working Group Preliminary Report and Recommendations, and Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations
• CDRH Preliminary Internal Evaluations -- Foreword: A Message from the Center Director
• CDRH Preliminary Internal Evaluations -- Volume I: 510(k) Working Group Preliminary Report and Recommendations
• CDRH Preliminary Internal Evaluations -- Volume II: Task Force Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations
• Recognition and Use of Consensus Standards
• AAOS Comment on Draft Guidance - July 2003
• FDA Guidance - September 17, 2007
• Unique Device Identification
• Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage

Articles

• AAOS Now Publications

Symposia, Courses and Workshops

• Workshop on Metal-on-Metal Total Hip Replacement Devices – May 17, 2011 – ASTM F04 Committee Week, Marriott Anaheim; Anaheim, CA

Scientific Exhibits (All in PDF format)

• 2012
• 2010
• 2009
• 2008
• 2007
• 2006
• 2003
• 2002-1
• 2002-2
• 2001-1
• 2001-2
• 2000-1
• 2000-2
• 1999-1
• 1999-2

Upcoming Meetings

• 2011
• February 15-19, 2011: AAOS Annual Meeting, San Diego, CA
• May 17-20, 2011: ASTM F04 May Committee Week, Anaheim, CA
• May 17: ASTM F04 – Workshop on Metal on Metal Total Hip Replacement Devices, Marriott Anaheim; Anaheim, CA
• November 15-18, 2011: ASTM F04 November Committee Week, Tampa, FL
• November 15, 2011: Biomedical Engineering Fall Committee Meeting, Tampa, FL
• 2012
• February 7-11, 2012: AAOS Annual Meeting, San Francisco, CA
• May 8-11, 2012: ASTM F04 May Committee Week, Phoenix, AZ
• November 13-16, 2012: ASTM F04 November Committee Week, Atlanta, GA

Resources

• Food and Drug Administration (FDA)
• FDA Center for Devices and Radiological Health (CDRH)
• FDA Orthopaedic and Rehabilitation Devices Panel
• MedWatch
• ASTM
• ISO Technical Committee 150

Committee Information

• Charges and Structure
• Member List and Staff Liaison/contact