Industry Consultant & Former FDA Biomedical Engineer


M.S.        Biomedical Engineering, University of Alabama Birmingham (1992)

B.S.        Biomedical Engineering, Tulane University (1989)


Industry Consultant

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 many years’ experience with decisions regarding combination products, particularly dental and wound products. Has extensive experience with dental implant 510ks and significant experience with bone filling materials, orthodontic aligners, and 3D printing resins for dental uses. Has experience with masks for both FDA and NIOSH processes and can help determine the best paths for your specific mask design. Is familiar with all the current EUA requirements for different mask types. Can help sort out device registration, listing and importation issues and will act as US Agent.

Consulting Firm

Catawba, NC (Oct. 2007 – 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

FDA/CDRH/ODE/DAGID, Dental Devices Branch, Biomedical Engineer 

Rockville, MD         (Mar. 1994 – 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.
  • 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:
  • Tissue engineered dental bone grafting materials
  • Oral wound dressings
  • Lubricants for dental hand pieces
  • Endosseous dental implants, including their abutments and CAD/CAM systems used for designing them in the dental office
  • Temporomandibular joint prostheses
  • Oral and maxillofacial bone plates, screws and distractors


Course Title



American Association of Dental Research Annual Meeting


March 2007

TMJ Bioengineering Conference

NIH, University of Kansas

May 2006

American Association of Dental Research Annual Meeting


March 2006

Advancing the Frontiers of Bioscience and Nanotechnology


June 2005

Methods for Enhancing the Efficiency of Dental/Oral Health Clinical Trials: Current Status, Future Possibilities


May 2004

American Association for Dental Research Annual Meeting


March 2004

Syposium on Metrology and Standards for Cell Signaling: Impact on Tissue Engineering


October 2003

Engineering Tissue Growth International Conference and Exposition

Pittsburgh Tissue Engineering Initiative

March 2003

Combination Products: Intercenter Collaborative Review


October 2002

21st Southern Biomedical Engineering Conference

Southern Biomedical Engineering Conference

September 2002

Surfaces in Biomaterials


Jan. and Feb. 2002

Advances in Tissue and Genetic Engineering for the Treatment of Arthritic Diseases

The Knowledge Foundation

September 2000

Reference Data for Biomaterials



July 2000

Gordon Research Conference on Tissue Engineering, Biomaterials and Biocompatibility

Gordon Research Conference

July 1999

International Symposium on Advanced Materials with Biomedical Applications


June 1999

Regulations Writing Course


January 1999

Special Topics in Biomaterials


August 1998

Tissue Engineering III


February 1998

Gordon Research Conference on Biomaterials: Biocompatibility/Tissue Engineering

Gordon Research Conference

July 1997

Assessment of Medical Devices Polymers


October 1996

Introduction to and Current Perspectives on Tissue Engineering


June 1996

Interface of Biomechanics and Cell Biology in Orthopedics

Johns Hopkins

June 1996

Cells and Materials

Scanning Microscopy International

May 1996

Biological Response to Orthopedic Implants

Johns Hopkins

April 1996

Tissue Engineering


February 1996

1996 Joint Symposium on Clinical Trial Design and Analysis in Periodontics


Jan-Feb. 1996

Gordon Research Conference on Biocompatibility and Biomaterials

Gordan Research Conference

July 1995

Total Joint Replacement Workshop


March 1995

Workshop on Tissue Engineering


November 1994


Award (Date)

Awarding Organization


FDA Outstanding Service Award (2006)


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 pre-market submissions.

Letter of Appreciation (2004)


For serving as a center standards liaison representative and STG member

Award of Appreciation (2001)


In appreciation of your outstanding efforts on ASTM Committee F4

CDRH Special Recognition Award (2000)


For significant service and dedication to the Office of Device Evaluation as ODE Division Focal Points.

Certificate of Appreciation (1997)


For your dedication to ODE as shown by your willingness to serve as an ODE Focal Point in addition to performing your regular duties.

FDA Group Recognition Award (1996)


For participation in the FDA Intercenter Tissue Engineering Working Group

FDA Group Recognition Award (1995)


For successful implementation of new initiatives, new management techniques and an increase in productivity since their inception in fiscal year 1994.


  • 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
  • FDA Liaison to ISO TC 106 Dentistry SC8 Dental Implants
  • FDA Liaison to ISO TC 106 Dentistry Working Group on Biocompatibility
  • FDA Liaison to ADA/ANSI Subtag of ISO TC 106


Member of University of Alabama Birmingham Department of Biomedical Engineering

Advisory Group


Chairperson of the CDRH Biocompatibility Assessment Group

DAGID Biocompatibility Focal Point

Mentoring of new DAGID biomedical engineers



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, 32,419-424 (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).


ISO/CD 22794 Dentistry – Implantable materials for bone reconstruction in oral and maxillofacial surgery – Contents of a technical file.

ISO 22803 Dentistry – Membrane materials for guided tissue regeneration in oral and maxillofacial surgery – Contents of a technical file. September 1, 2004.

Dental Devices; Reclassification of Root-Form Endosseous Dental Implants and Endosseous Implant Abutments. Final Rule. Federal Register 69, 92 May 12, 2004.

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. May 12, 2004.

ISO 14801 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, 2000.

American National Standard/American Dental Association Standard No. 127 Fatigue Testing for Endosseous Dental Implants June 6, 2012.

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