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)

• IOM 510(k) Recommendations
• FDA Public Meeting “Strengthening the Center for Device and Radiological Health’s 510(k) review process”
• FDA Science Board Science and Technology Subcommittee Report, “FDA Science and Mission at Risk”
• FDA Proposed Rule for the Unique Device Identification System
• Posterior Cervical Screw Classification
• Communications and Activities Related to Off-Label Uses of Marketed Products and Use of Products Not Yet Legally Marketed
• Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices
• Design Consideration for Pivotal Clinical Investigations for Medical Devices
• Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review
• Procedures for Handling Section 522 Postmarket Surveillance Studies
• Custom Device Exemption
• 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• Draft Guidance on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees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)

• 2013
• 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

• 2013
• May 21-24, 2013: ASTM F04 May Committee Week, Indianapolis, IN
• May 21, 2013: ASTM F04 – Workshop on “Standards and Measurements for Tissue Engineering Scaffolds: What Do We Have? What Do We Need?”, JW Marriott Indianapolis; Indianapolis, IN
• November 12-15, 2013: ASTM F04 November Committee Week, Jacksonville, FL
• 2014
• May 6-9, 2014: ASTM F04 May Committee Week, Toronto, Ontario, CA
• November 11-14, 2014: ASTM F04 November Committee Week, New Orleans, LA

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