Curriculum Vitae. EDUCATION M.S. Biomedical Engineering, University of Alabama Birmingham (1992) B.S. Biomedical Engineering, Tulane University (1989)
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1 Curriculum Vitae Angela Blackwell, M.S. Senior Consultant Blackwell Device Consulting. Portland, OR EDUCATION M.S. Biomedical Engineering, University of Alabama Birmingham (1992) B.S. Biomedical Engineering, Tulane University (1989) EXPERIENCE Blackwell Device Consulting, Senior Consultant and Proprietor Portland, OR (July 2012 Present) Advise clients on many aspects of pre-market decision making such as testing, classification, regulatory path, and implications of device design changes. Write or edit regulatory submissions of all types including 513g, RFD, pre-sub, IDE, 510k, and PMA. Has extensive experience with decisions regarding combination products, particularly dental and wound products. Biologics Consulting Group, Inc., Senior Consultant Catawba, NC (Oct July 2012) Advised companies on engineering, preclinical and biocompatibility testing Experienced with regulatory submissions for many types of devices and combination products Examples of device types include dental implants, dental implant abutments (including patient specific CAD/CAM abutments), dental impression materials, wound dressings, and bone filling materials /CDRH/ODE/DAGID, Dental Devices Branch, Biomedical Engineer Rockville, MD (Mar Sept. 2007) Extensive experience in review of 510ks including some for implantable devices which contain clinical data and some for device /drug combinations (oral wound dressings). Over thirteen years of experience reviewing IDEs including those which result in both PMAs and 510ks. Nine years of experience as a PMA team leader for 5 companies products. This involves coordinating with reviewers from different areas, editing their reviews, and making everything into an overall review. Also involves writing the PMA summary which is released when the product is approved. Updated: October 2017 Page 1 of 5
2 Reviewed many requests for classification (513g) and requests for designation, and am familiar with these processes and how they involve interaction with the Program Operations Staff and the Office of Combination Products. Long term projects with combination products involved working with CDER, ODE clinicians, statisticians, and patient labeling staff to approve clinical trials for dental bone filling materials containing therapeutic proteins and then reviewing the PMA. Served as team leader for the first bone filling material PMA approved which contained PDGF and also for the first dental bone filling material PMA approved which contained rhbmp-2. Worked on the rhbmp-2 project for thirteen years and the PDGF project for six years. Served as senior engineer for the following product areas: o tissue engineered dental bone grafting materials, o oral wound dressings, o lubricants for dental hand pieces, o endosseous dental implants, including their abutments and CAD/CAM systems used for designing them in the dental office o temporomandibular joint prostheses, o oral and maxillofacial bone plates, screws and distractors CONTINUING EDUCATION Course Title Sponsor Date American Association of Dental Research IADR/AADR March 2007 TMJ Bioengineering NIH, University of Kansas May 2006 American Association of Dental Research AADR March 2006 Advancing the Frontiers of Bioscience and NIST June 2005 Nanotechnology Methods for Enhancing the Efficiency of NIH May 2004 Dental/Oral Health Clinical Trials: Current Status, Future Possibilities American Association for Dental Research IADR/AADR March 2004 Syposium on Metrology and Standards for NIST October 2003 Cell Signaling: Impact on Tissue Engineering Engineering Tissue Growth International Pittsburgh Tissue March 2003 and Exposition Engineering Initiative Combination Products: Intercenter October 2002 Collaborative Review 21 st Southern Biomedical Engineering Southern Biomedical September 2002 Engineering Surfaces in Biomaterials Jan. and Feb Advances in Tissue and Genetic Engineering The Knowledge Foundation September 2000 Updated: October 2017 Page 2 of 5
3 Course Title Sponsor Date for the Treatment of Arthritic Diseases Reference Data for Biomaterials NIST July 2000 Workshop Gordon Research on Tissue Gordon Research July 1999 Engineering, Biomaterials and Biocompatibility International Symposium on Advanced NIST June 1999 Materials with Biomedical Applications Regulations Writing Course January 1999 Special Topics in Biomaterials UMBC August 1998 Tissue Engineering III February 1998 Gordon Research on Biomaterials: Biocompatibility/Tissue Engineering Gordon Research July 1997 Assessment of Medical Devices Polymers October 1996 Introduction to and Current Perspectives on NIH June 1996 Tissue Engineering Interface of Biomechanics and Cell Biology in Orthopedics Johns Hopkins June 1996 Cells and Materials Scanning Microscopy May 1996 International Biological Response to Orthopedic Implants Johns Hopkins April 1996 Tissue Engineering February Joint Symposium on Clinical Trial NIH Jan-Feb Design and Analysis in Periodontics Gordon Research on Gordan Research July 1995 Biocompatibility and Biomaterials Total Joint Replacement Workshop NIST March 1995 Workshop on Tissue Engineering NIST November 1994 HONORS & AWARDS Award (Date) Outstanding Service Award (2006) Awarding Organization Citation CDRH Premarket Submission Quality Review Group: For exceptional performance and participation in the Center s pilot program to assess the quality of biocompatibility, sterilization, and statistical reviews of premarket submissions. For serving as a center standards liaison representative and STG member Letter of Appreciation (2004) Award of Appreciation ASTM In appreciation of your outstanding efforts on Updated: October 2017 Page 3 of 5
4 Award (Date) Awarding Citation Organization (2001) ASTM Committee F4 CDRH Special Recognition Award (2000) For significant service and dedication to the Office of Device Evaluation as ODE Division Certificate of Appreciation (1997) Group Recognition Award (1996) Group Recognition Award (1995) Focal Points. For your dedication to ODE as shown by your willingness to serve as an ODE Focal Point in addition to performing your regular duties. For participation in the Intercenter Tissue Engineering Working Group For successful implementation of new initiatives, new management techniques and an increase in productivity since their inception in fiscal year PARTICIPATION IN INTERNATIONAL AND NATIONAL STANDARDS ORGANIZATIONS U.S. Expert to ISO TC 106 SC8 Dental Implants Working Group On Mechanical Testing ADA/ANSI Subtag to ISO TC 106 SC8 Working Group Chairperson on Mechanical Testing of Dental Implants Liaison to ISO TC 106 Dentistry SC8 Dental Implants Liaison to ISO TC 106 Dentistry Working Group on Biocompatibility Liaison to ADA/ANSI Subtag of ISO TC 106 OUTSIDE PROFESSIONAL ADVISORY AND CONSULTING ACTIVITIES Member of University of Alabama Birmingham Department of Biomedical Engineering Advisory Group SPECIAL ASSIGNMENTS AND ADVISORY ACTIVITIES Chairperson of the CDRH Biocompatibility Assessment Group DAGID Biocompatibility Focal Point Mentoring of new DAGID biomedical engineers PUBLICATIONS Charlene M. Flahiff, Angela S. Blackwell, J. Marcus Hollis, and Dale S. Feldman. Analysis of a biodegradable composite for bone healing, Journal of Biomedical Materials Research, 32, (1996). A.E. Steedley (maiden name), R.C. Anderson, M.W. Bidez, D.S.Feldman. Finite Element Model of a Biodegradable Intrameduallary Rod, Transactions of the Society for Biomaterials, 16, 51 (1990). OTHER PUBLICATIONS ISO/CD Dentistry Implantable materials for bone reconstruction in oral and maxillofacial surgery Contents of a technical file. Updated: October 2017 Page 4 of 5
5 ISO Dentistry Membrane materials for guided tissue regeneration in oral and maxillofacial surgery Contents of a technical file. September 1, Dental Devices; Reclassification of Root-Form Endosseous Dental Implants and Endosseous Implant Abutments. Final Rule. Federal Register 69, 92 May 12, Guidance for Industry and Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. May 12, ISO Dentistry Fatigue testing for endosseous dental implants. May 13, 2003 and subsequent revisions. Dental Products Devices; Reclassification of Endosseous Dental Implant Accessories. Final Rule. Federal Register 65, 196 October 10, American National Standard/American Dental Association Standard No. 127 Fatigue Testing for Endosseous Dental Implants June 6, Updated: October 2017 Page 5 of 5
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