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Standards Program

CDRH International and National Liaison Roster
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(as of 6/8/2008)

ORG COMMITTEE SUB-COMMITTEE WORKING GROUP SUB-WORKING GROUP MEMBER
AAMI

AD, Aids for Ostomy and Incontinence (U.S. TAG for ISO TC 173, SC 3)      
AAMI AP, Apnea Monitoring Committee      
PRIMARY:  JEFFREY  L  SILBERBERG,  (CDRH, OSEL)
AAMI AT, Autologous Transfusion Committee      
PRIMARY:  CATHERINE  P  WENTZ,  (CDRH, ODE)
AAMI BE, Biological Evaluation Committee   WG 01, Systematic approach to biological evaluation and terminology  
PRIMARY:  JENNIFER  L  GOODE,  (CDRH, ODE)
ALTERNATE:  MELVIN  E  STRATMEYER,  (CDRH, OSEL)
AAMI BE, Biological Evaluation Committee   WG 02, Degradation aspects related to biological testing  
ALTERNATE:  AUBREY  D  GANTT JR,  (CDRH, ODE)
PRIMARY:  SCOTT  G  MCNAMEE,  (CDRH, OC)
AAMI BE, Biological Evaluation Committee   WG 03, Animal protection aspects  
PRIMARY:  MELVIN  E  STRATMEYER,  (CDRH, OSEL)
AAMI

BE, Biological Evaluation Committee   WG 04, Clinical investigations of medical devices in humans  
PRIMARY:  KIMBER  C  RICHTER,  (CDRH, OC)
ALTERNATE:  MARIAN  J  SERGE,  (CDRH, OC)
AAMI BE, Biological Evaluation Committee   WG 05, Cytotoxicity  
PRIMARY:  VICTORIA  M  HITCHINS,  (CDRH, OSEL)
ALTERNATE:  JEFFREY    TOY,  (CDRH, ODE)
AAMI

BE, Biological Evaluation Committee   WG 06, Mutagenicity, cancerogenicity and reproductive toxicity  
ALTERNATE:  RAMESH    PANGULURI,  (CDRH, ODE)
PRIMARY:  JEFFREY    TOY,  (CDRH, ODE)
AAMI BE, Biological Evaluation Committee   WG 07, Systemic toxicity  
ALTERNATE:  RONALD  P  BROWN,  (CDRH, OSEL)
PRIMARY:  MELVIN  E  STRATMEYER,  (CDRH, OSEL)
AAMI

BE, Biological Evaluation Committee   WG 08, Irritation and sensitization  
PRIMARY:  VASANT  G  MALSHET,  (CDRH, ODE)
ALTERNATE:  MRIDULIKA    VIRMANI,  (CDRH, ODE)
AAMI BE, Biological Evaluation Committee   WG 09, Effects on blood  
PRIMARY:  JENNIFER  L  GOODE,  (CDRH, ODE)
ALTERNATE:  WILLIAM  G  LETZING,  (CDRH, ODE)
AAMI BE, Biological Evaluation Committee   WG 10, Implantation  
PRIMARY:  VASANT  G  MALSHET,  (CDRH, ODE)
ALTERNATE:  JEFFREY    TOY,  (CDRH, ODE)
AAMI BE, Biological Evaluation Committee   WG 11, Allowable limits for leachable substances  
PRIMARY:  RONALD  P  BROWN,  (CDRH, OSEL)
ALTERNATE:  MELVIN  E  STRATMEYER,  (CDRH, OSEL)
AAMI

BE, Biological Evaluation Committee   WG 12, Sample preparation and reference materials  
ALTERNATE:  KAREEM  S  BURNEY,  (CDRH, ODE)
PRIMARY:  DONALD  E  MARLOWE,  (OC, OSHC)
AAMI BE, Biological Evaluation Committee   WG 13, Toxicokinetics study  
ALTERNATE:  RONALD  P  BROWN,  (CDRH, OSEL)
PRIMARY:  HOAN MY  D  LUU,  (CDRH, OSEL)
AAMI BE, Biological Evaluation Committee   WG 14, Material characterization  
ALTERNATE:  IRADA  S  ISAYEVA,  (CDRH, OSEL)
PRIMARY:  STEVEN    POLLACK,  (CDRH, OSEL)
AAMI BE, Biological Evaluation Committee   WG 15, Strategic approach to biological assessment  
ALTERNATE:  RONALD  P  BROWN,  (CDRH, OSEL)
PRIMARY:  MELVIN  E  STRATMEYER,  (CDRH, OSEL)
AAMI

BE, Biological Evaluation Committee   WG 16, Pyrogenicity  
PRIMARY:  VICTORIA  M  HITCHINS,  (CDRH, OSEL)
AAMI

BE, Biological Evaluation Committee (U.S. TAG for ISO TC 194)      
ALTERNATE:  DONALD  E  MARLOWE,  (OC, OSHC)
PRIMARY:  MELVIN  E  STRATMEYER,  (CDRH, OSEL)
AAMI BG, Blood/Gas Exchange Device Committee      
PRIMARY:  ARTHUR  A  CIARKOWSKI,  (CDRH, ODE)
ALTERNATE:  RONALD  A  ROBINSON,  (CDRH, OSEL)
AAMI BG, Blood/Gas Exchange Device Committee SC 02 Cardiovascular implants WG 06, Vascular device/drug combination products  
PRIMARY:  JENNIFER  L  GOODE,  (CDRH, ODE)
ALTERNATE:  HINA  M  PINTO,  (CDRH, ODE)
AAMI Board Healthcare Administration Vice Chair      
PRIMARY:  KIMBER  C  RICHTER,  (CDRH, OC)
AAMI Board of Directors      
PRIMARY:  KIMBER  C  RICHTER,  (CDRH, OC)
AAMI BP, Blood Pressure Monitoring Committee      
PRIMARY:  CHARLES  S  HO,  (CDRH, ODE)
AAMI CI, Cochlear Implants Committee      
TECH EXPERT:  BRIAN  B  BEARD,  (CDRH, OSEL)
PRIMARY:  JAMES  K  KANE,  (CDRH, ODE)
TECH EXPERT:  VICTOR    KRAUTHAMMER,  (CDRH, OSEL)
ALTERNATE:  SRINIVAS    NANDKUMAR,  (CDRH, ODE)
AAMI Committee on Standards Strategy      
PRIMARY:  CAROL  L  HERMAN,  (CDRH, OSEL)
PRIMARY:  DONALD  E  MARLOWE,  (OC, OSHC)
AAMI CV, Cardiac Valve Prostheses Committee      
PRIMARY:  SANDY  F  STEWART,  (CDRH, OSEL)
AAMI DF, Defibrillator Committee      
PRIMARY:  CAROLE  C  CAREY,  (CDRH, ODE)
AAMI

DI, Medical Devices for Injections Committee (U.S. TAG for ISO TC 84)   WG 01, Needle-free injections working group  
PRIMARY:  LANA  L  SHIU,  (CDRH, ODE)
ALTERNATE:  PANDU  R  SOPREY,  (CDRH, ODE)
AAMI DI, Medical Devices for Injections Committee (U.S. TAG for ISO TC 84)   WG 05, Joint TC 84 - TC 76 - TC 121/SC 03 WG: Pulmonary devices  
ALTERNATE:  MICHAEL  J  HUSBAND,  (CDRH, ODE)
PRIMARY:  WILLIAM  C  MALONEY,  (CDRH, OC)
AAMI DP, Medical Device Particulates Committee      
PRIMARY:  DINESH  V  PATWARDHAN,  (CDRH, OSEL)
ALTERNATE:  HINA  M  PINTO,  (CDRH, ODE)
AAMI EC   WG 01, Ambulatory electrocardiograph  
ALTERNATE:  BENJAMIN  C  ELOFF,  (CDRH, OSEL)
PRIMARY:  CHARLES  S  HO,  (CDRH, ODE)
AAMI EC   WG 02, Arrhythmia monitoring  
PRIMARY:  CAROLE  C  CAREY,  (CDRH, ODE)
AAMI EC   WG 03, Cables and leads  
PRIMARY:  CAROLE  C  CAREY,  (CDRH, ODE)
AAMI

EC   WG 04, Cardiac monitor and diagnostic ECG  
PRIMARY:  CHARLES  S  HO,  (CDRH, ODE)
AAMI EC   WG 06, ECG Electrode  
PRIMARY:  CAROLE  C  CAREY,  (CDRH, ODE)
AAMI EC   WG 08, Standard communications protocol  
PRIMARY:  CHARLES  S  HO,  (CDRH, ODE)
AAMI EC, ECG Committee      
PRIMARY:  CAROLE  C  CAREY,  (CDRH, ODE)
AAMI

EM, Electromagnetic Compatibility Committee      
PRIMARY:  JEFFREY  L  SILBERBERG,  (CDRH, OSEL)
ALTERNATE:  DONALD  M  WITTERS JR,  (CDRH, OSEL)
AAMI

EQ, Medical Equipment Management Committee      
AAMI

EV, (U.S. sub-TAG for IEC 62D Electromedical equipment)   WG 04, Electro-optical equipment sub-TAG  
PRIMARY:  NEIL R P    OGDEN,  (CDRH, ODE)
AAMI

EV, (U.S. sub-TAG for IEC 62D Electromedical equipment)   WG 05, Hospital beds sub-TAG  
PRIMARY:  JOAN    FERLO TODD,  (CDRH, OSB)
ALTERNATE:  MATTHEW  J  POWERS,  (CDRH, OC)
ALTERNATE:  MATTHEW  R  SCHWERIN,  (CDRH, OSEL)
AAMI EV, (U.S. sub-TAG for IEC 62D Electromedical equipment)   WG 09, Lung ventilators  
PRIMARY:  MELANIE    CHOE,  (CDRH, ODE)
ALTERNATE:  JENNIFER  R  MEDICUS,  (CDRH, OC)
AAMI

EV, (U.S. sub-TAG for IEC 62D Electromedical equipment)   WG 12, Luminaires sub-TAG  
AAMI

EV, (U.S. sub-TAG for IEC 62D Electromedical equipment)   WG 13, Lens removal and vitrectomy devices for ophthalmic surgery sub-TAG  
PRIMARY:  DEXIU    SHI,  (CDRH, ODE)
AAMI

HE, Human Factors Engineering Committee      
PRIMARY:  PETER  B  CARSTENSEN,  (CDRH, OCER)
ALTERNATE:  RONALD  D  KAYE,  (CDRH, OCER)
AAMI

HF, High Frequency Therapeutic Device Committee (U.S. sub-TAG for IEC 62D, MT 17)      
ALTERNATE:  LONG  H  CHEN,  (CDRH, ODE)
PRIMARY:  ROXOLANA  I  HORBOWYJ,  (CDRH, ODE)
AAMI

ID, Infusion Device Committee (U.S. sub-TAG for IEC 62D, MT 23 & ISO TC 150, SC 6, WG 4)      
PRIMARY:  ALAN  M  STEVENS,  (CDRH, OC)
AAMI ID, Infusion Device Committee (U.S. sub-TAG for IEC 62D, MT 23 & ISO TC 150, SC 6, WG 4)   WG 01, Enteral administration sets connector  
PRIMARY:  EILEEN  K  WOO,  (CDRH, OSB)
AAMI

II, Infant Incubator Committee (U.S. sub-TAG for IEC 62D, MT 21)      
ALTERNATE:  WILLIAM  M  BURDICK,  (CDRH, ODE)
PRIMARY:  NANCY  A  PRESSLY,  (CDRH, OSB)
AAMI MC, Mechanical Circulatory Support Device Evaluation - Preclinical testing      
PRIMARY:  ERIC  A  CHEN,  (CDRH, ODE)
PRIMARY:  SONNA  M  PATEL-RAMAN,  (CDRH, ODE)
AAMI MC, Mechanical Circulatory Support Systems Committee      
PRIMARY:  MICHAEL  R  BERMAN,  (CDRH, OSEL)
ALTERNATE:  JEAN  E  RINALDI,  (CDRH, OSEL)
AAMI

Medical Device Software Committee      
TECH EXPERT:  BRIAN  J  FITZGERALD,  (CDRH, OSEL)
PRIMARY:  JOHN  F  MURRAY JR,  (CDRH, OC)
ALTERNATE:  DONNA BEA    TILLMAN,  (CDRH, ODE)
AAMI Medical Device Software Committee Executive Board    
PRIMARY:  JOHN  F  MURRAY JR,  (CDRH, OC)
ALTERNATE:  DONNA BEA    TILLMAN,  (CDRH, ODE)
AAMI NS, Neurosurgery Committee      
PRIMARY:  ROBERT  J  DE LUCA,  (CDRH, ODE)
AAMI NS, Neurosurgery Committee   WG 02, Implantable neurostimulator  
PRIMARY:  STEPHEN  M  HINCKLEY,  (CDRH, ODE)
ALTERNATE:  VICTOR    KRAUTHAMMER,  (CDRH, OSEL)
AAMI NS, Neurosurgery Committee   WG 03, Transcutaneous electrical stimulator  
PRIMARY:  ROBERT  J  DE LUCA,  (CDRH, ODE)
AAMI

PB, Protective Barriers Committee      
PRIMARY:  TERRELL  A  CUNNINGHAM,  (CDRH, ODE)
ALTERNATE:  SHEILA  A  MURPHEY,  (CDRH, ODE)
AAMI

PC, Cardiac Rhythm Management Device Committee      
ALTERNATE:  SETH    SEIDMAN,  (CDRH, OSEL)
PRIMARY:  MITCHELL  J  SHEIN,  (CDRH, ODE)
AAMI QM, Quality Management and Corresponding General Aspects for Medical Devices   WG 01, Application of quality systems to medical devices  
PRIMARY:  KIMBERLY  A  TRAUTMAN,  (CDRH, OC)
ALTERNATE:  JAN    WELCH,  (CDRH, OC)
AAMI QM, Quality Management and Corresponding General Aspects for Medical Devices   WG 02, General aspects stemming from the application of quality principles to medical devices  
PRIMARY:  ERIN  I  KEITH,  (CDRH, OC)
AAMI

QM, Quality Management and Corresponding General Aspects for Medical Devices   WG 03, Symbols and nomenclature for medical devices  
PRIMARY:  CAROL  L  HERMAN,  (CDRH, OSEL)
ALTERNATE:  VICTORIA    WAGMAN,  (CDRH, OSEL)
AAMI

QM, Quality Management and Corresponding General Aspects for Medical Devices   WG 04, Application of risk management to medical devices  
ALTERNATE:  ARTHUR  A  CIARKOWSKI,  (CDRH, ODE)
PRIMARY:  WILLIAM  H  MIDGETTE,  (CDRH, OSEL)
AAMI

QM, Quality Management and Corresponding General Aspects for Medical Devices (US TAG for ISO/TC 210)      
PRIMARY:  CAROL  L  HERMAN,  (CDRH, OSEL)
ALTERNATE:  KIMBERLY  A  TRAUTMAN,  (CDRH, OC)
AAMI

RD, Renal Disease and Detoxification Committee (U.S. sub-TAG for IEC 62D      
PRIMARY:  GEMA    GONZALEZ,  (CDRH, ODE)
AAMI

SP, Sphygmomanometer Committee      
PRIMARY:  CHARLES  S  HO,  (CDRH, ODE)
AAMI Standards Board      
PRIMARY:  CAROL  L  HERMAN,  (CDRH, OSEL)
AAMI

Sterilization Standards Committee   WG 01, Industrial EO sterilization  
ALTERNATE:  JOHN  M  KUCHINSKI,  (CDRH, ODE)
PRIMARY:  STEVEN  E  TURTIL,  (CDRH, ODE)
AAMI

Sterilization Standards Committee   WG 02, Radiation sterilization  
ALTERNATE:  HARRY  F  BUSHAR,  (CDRH, OSB)
ALTERNATE:  MARY ANNE    MALARKEY,  (CBER, OCBQ)
PRIMARY:  PATRICK  B  WEIXEL,  (CDRH, OC)
AAMI

Sterilization Standards Committee   WG 03, Industrial moist heat sterilization  
ALTERNATE:  GEETHA  C  JAYAN,  (ODE, DAGID)
PRIMARY:  ELIZABETH  A  RIEGEL,  (CDRH, OC)
AAMI

Sterilization Standards Committee   WG 04, Biological indicators  
ALTERNATE:  CHRISTOPHE  A  DEMITRUS,  (ORA, NE-FO)
PRIMARY:  CANDACE    MCMANUS,  (CDRH, OC)
AAMI Sterilization Standards Committee   WG 05, Sterilization terminology  
PRIMARY:  VICTORIA  M  HITCHINS,  (CDRH, OSEL)
ALTERNATE:  SHARON KAY    LAPPALAINEN,  (CDRH, ODE)
AAMI

Sterilization Standards Committee   WG 06, Chemical indicators  
ALTERNATE:  MICHELLE    RIOS,  (CDRH, ODE)
PRIMARY:  JENNIFER  L  SCHMIDT,  (CDRH, ODE)
AAMI

Sterilization Standards Committee   WG 07, Packaging  
PRIMARY:  VICTORIA  M  HITCHINS,  (CDRH, OSEL)
ALTERNATE:  STEVEN  E  TURTIL,  (CDRH, ODE)
AAMI

Sterilization Standards Committee   WG 08, Microbiological methods  
PRIMARY:  VICTORIA  M  HITCHINS,  (CDRH, OSEL)
ALTERNATE:  SHARON KAY    LAPPALAINEN,  (CDRH, ODE)
AAMI

Sterilization Standards Committee   WG 09, Aseptic processing  
PRIMARY:  THOMAS  J  ARISTA,  (ORA, ORO)
ALTERNATE:  ELAINE  S  MAYHALL,  (CDRH, ODE)
AAMI

Sterilization Standards Committee   WG 10, Liquid chemical sterilization  
ALTERNATE:  KEVIN  D  KALLANDER,  (ORA, SW-FO)
PRIMARY:  CANDACE    MCMANUS,  (CDRH, OC)
AAMI

Sterilization Standards Committee   WG 11, General criteria for sterilization processes  
PRIMARY:  CHIU  S  LIN,  (CDRH, ODE)
ALTERNATE:  ALLISON  A  RODRIGUEZ,  (ORA, NE-FO)
AAMI Sterilization Standards Committee   WG 12, Instructions for reusable device reprocessing  
PRIMARY:  CHIU  S  LIN,  (CDRH, ODE)
ALTERNATE:  STEVEN  E  TURTIL,  (CDRH, ODE)
AAMI

Sterilization Standards Committee   WG 13, Washer-disinfectors  
ALTERNATE:  VICTORIA  M  HITCHINS,  (CDRH, OSEL)
PRIMARY:  CHIU  S  LIN,  (CDRH, ODE)
AAMI

Sterilization Standards Committee   WG 40, Steam sterilization hospital practices  
PRIMARY:  CANDACE    MCMANUS,  (CDRH, OC)
ALTERNATE:  ELIZABETH  A  RIEGEL,  (CDRH, OC)
AAMI Sterilization Standards Committee   WG 42, Dry heat sterilization  
PRIMARY:  ELAINE  S  MAYHALL,  (CDRH, ODE)
ALTERNATE:  JENNIFER  L  SCHMIDT,  (CDRH, ODE)
AAMI

Sterilization Standards Committee   WG 43, Hospital steam sterilizer  
ALTERNATE:  SHEILA  A  MURPHEY,  (CDRH, ODE)
PRIMARY:  ELIZABETH  A  RIEGEL,  (CDRH, OC)
AAMI

Sterilization Standards Committee   WG 60, EO Sterilization hospital practices  
ALTERNATE:  CHRISTOPHE  A  DEMITRUS,  (ORA, NE-FO)
PRIMARY:  STEVEN  E  TURTIL,  (CDRH, ODE)
AAMI Sterilization Standards Committee   WG 61, Chemical sterilants hospital practices  
ALTERNATE:  ELIZABETH  D  GONZALES,  (ORA, SW-FO)
PRIMARY:  CANDACE    MCMANUS,  (CDRH, OC)
AAMI Sterilization Standards Committee   WG 62, Hospital EO sterilizer  
ALTERNATE:  JENNIFER  L  SCHMIDT,  (CDRH, ODE)
PRIMARY:  STEVEN  E  TURTIL,  (CDRH, ODE)
AAMI Sterilization Standards Committee   WG 63, Sterilization residuals  
PRIMARY:  ANNE  D  LUCAS,  (CDRH, OSEL)
ALTERNATE:  RAMESH    PANGULURI,  (CDRH, ODE)
AAMI Sterilization Standards Committee   WG 82, Decontamination  
PRIMARY:  VICTORIA  M  HITCHINS,  (CDRH, OSEL)
ALTERNATE:  SHARON KAY    LAPPALAINEN,  (CDRH, ODE)
AAMI

Sterilization Standards Committee   WG 83, Reusable surgical textiles processing  
PRIMARY:  SHARON KAY    LAPPALAINEN,  (CDRH, ODE)
ALTERNATE:  SHEILA  A  MURPHEY,  (CDRH, ODE)
AAMI Sterilization Standards Committee   WG 90, Microbiological quality (SALs) of processed medical devices  
PRIMARY:  VICTORIA  M  HITCHINS,  (CDRH, OSEL)
ALTERNATE:  SHARON KAY    LAPPALAINEN,  (CDRH, ODE)
AAMI Sterilization Standards Committee   WG 91, Resistometer  
PRIMARY:  CHRISTOPHE  A  DEMITRUS,  (ORA, NE-FO)
ALTERNATE:  ELAINE  S  MAYHALL,  (CDRH, ODE)
AAMI

Sterilization Standards Committee   WG 92, Process challenge devices  
ALTERNATE:  GEETHA  C  JAYAN,  (ODE, DAGID)
PRIMARY:  CHIU  S  LIN,  (CDRH, ODE)
AAMI Sterilization Standards Committee   WG 93, Cleaning of reusable medical devices  
PRIMARY:  VICTORIA  M  HITCHINS,  (CDRH, OSEL)
ALTERNATE:  STEVEN  E  TURTIL,  (CDRH, ODE)
AAMI

Sterilization Standards Committee   WG 94, Rigid sterilization container systems  
PRIMARY:  GEETHA  C  JAYAN,  (ODE, DAGID)
ALTERNATE:  JENNIFER  L  SCHMIDT,  (CDRH, ODE)
AAMI

Sterilization Standards Committee   WG 95, Water quality for reprocessing medical devices  
ALTERNATE:  HENRY  S  CHAN,  (CDRH, OCER)
PRIMARY:  CANDACE    MCMANUS,  (CDRH, OC)
AAMI

Sterilization Standards Committee   WG 96, Compatibility of materials subject to sterilization  
PRIMARY:  ANNE  D  LUCAS,  (CDRH, OSEL)
ALTERNATE:  MICHAEL  D  OHARA,  (CDRH, OSEL)
AAMI Sterilization Standards Committee Executive Board U.S. TAG for ISO TC198  
PRIMARY:  VICTORIA  M  HITCHINS,  (CDRH, OSEL)
ALTERNATE:  CHIU  S  LIN,  (CDRH, ODE)
AAMI VP, Vascular Prostheses Committee      
PRIMARY:  DOROTHY  B  ABEL,  (CDRH, ODE)
ALTERNATE:  JENNIFER  L  GOODE,  (CDRH, ODE)
AAMI WV, Waveform Testing Committee      
PRIMARY:  SANDY    WEININGER,  (CDRH, OSEL)
AAPM Professional Council Government and Regulatory Affairs    
PRIMARY:  ROBERT  A  PHILLIPS,  (CDRH, ODE)
AAPM

Science Council Calibration Laboratory Accreditation Subcommittee    
PRIMARY:  MARY  D  WALKER,  (CDRH, OSEL)
AAPM Science Council Calibration Laboratory Accreditation Subcommittee TG 51 Calibration of non-compliant beams  
PRIMARY:  GAMAL    AKABANI,  (CDRH, ODE)
AAPM Science Council Diagnostic X-Ray Imaging    
PRIMARY:  ROBERT  A  PHILLIPS,  (CDRH, ODE)
AAPM Science Council Magnetic Resonance    
PRIMARY:  ROBERT  A  PHILLIPS,  (CDRH, ODE)
AAPM Science Council Radiation Protection    
PRIMARY:  ROBERT  A  PHILLIPS,  (CDRH, ODE)
AAPM Science Council Therapy Imaging    
PRIMARY:  GAMAL    AKABANI,  (CDRH, ODE)
AIUM AIUM/NEMA Joint Committee Output Standards Subcommittee (OSS)    
PRIMARY:  GERALD  R  HARRIS,  (CDRH, OSEL)
AIUM Bioeffects Committee      
PRIMARY:  MELVIN  E  STRATMEYER,  (CDRH, OSEL)
AIUM Technical Standards Committee      
PRIMARY:  KEITH  A  WEAR,  (CDRH, OSEL)
ANSI Accreditation Committee      
PRIMARY:  DONALD  E  MARLOWE,  (OC, OSHC)
ALTERNATE:  JOHN  F  MURRAY JR,  (CDRH, OC)
ANSI

Accredited Standards Committee C63 - Electromagnetic Compatibility (EMC)      
ALTERNATE:  JEFFREY  L  SILBERBERG,  (CDRH, OSEL)
ANSI Accredited Standards Committee C63 - Electromagnetic Compatibility (EMC) SC 01 Techniques and Development    
ALTERNATE:  JEFFREY  L  SILBERBERG,  (CDRH, OSEL)
ANSI Accredited Standards Committee C63 - Electromagnetic Compatibility (EMC) SC 05 Immunity Testing and Measurements    
ALTERNATE:  JEFFREY  L  SILBERBERG,  (CDRH, OSEL)
ANSI Accredited Standards Committee C63 - Electromagnetic Compatibility (EMC) SC 08 Medical Device EMC Test Methods    
ALTERNATE:  JEFFREY  L  SILBERBERG,  (CDRH, OSEL)
ALTERNATE:  DONALD  M  WITTERS JR,  (CDRH, OSEL)
ANSI Accredited Standards Committee C63 - Electromagnetic Compatibility (EMC) SC 08 Medical Device EMC Test Methods WG 01 Medical Device Ad Hoc EMC Test  
PRIMARY:  DONALD  M  WITTERS JR,  (CDRH, OSEL)
ANSI Accredited Standards Committee C63 - Electromagnetic Compatibility (EMC) SC 08 Medical Device EMC Test Methods WG 03 Hearing Aid Compatibility C63.19  
TECH EXPERT:  BRIAN  B  BEARD,  (CDRH, OSEL)
PRIMARY:  SRINIVAS    NANDKUMAR,  (CDRH, ODE)
ALTERNATE:  SHU-CHEN    PENG,  (CDRH, ODE)
ANSI Accredited Standards Committee on Bioacoustics S3      
PRIMARY:  JAMES  K  KANE,  (CDRH, ODE)
ANSI Accredited Standards Committee on Bioacoustics S3   WG 37 Coupler Calibration of Earphones  
ALTERNATE:  JAMES  K  KANE,  (CDRH, ODE)
PRIMARY:  SRINIVAS    NANDKUMAR,  (CDRH, ODE)
ANSI Accredited Standards Committee on Bioacoustics S3   WG 48 Hearing Aids  
PRIMARY:  JAMES  K  KANE,  (CDRH, ODE)
ANSI Accredited Standards committee on Bioacoustics S3   WG 80 Probe Tube Measurements of Hearing Aid Performance  
PRIMARY:  JAMES  K  KANE,  (CDRH, ODE)
ALTERNATE:  SHU-CHEN    PENG,  (CDRH, ODE)
ANSI Accredited Standards committee on Bioacoustics S3   WG 81 Hearing Assistance Technologies  
PRIMARY:  JAMES  K  KANE,  (CDRH, ODE)
ALTERNATE:  SHU-CHEN    PENG,  (CDRH, ODE)
ANSI Acoustical Standards Management Board (ASA)      
PRIMARY:  MELVIN  E  STRATMEYER,  (CDRH, OSEL)
ANSI ADA Standards Committee on Dental Products (ADA SCDP) (U.S. TAG for ISO/TC 106   JWG 01 Biological evaluation  
ALTERNATE:  MICHAEL  J  RYAN,  (CDRH, ODE)
ANSI ADA Standards Committee on Dental Products (ADA SCDP) (U.S. TAG for ISO/TC 106)      
ALTERNATE:  KEVIN  P  MULRY,  (CDRH, ODE)
PRIMARY:  MICHAEL  J  RYAN,  (CDRH, ODE)
ANSI B 11.21 Laser Safety for Machine Tools      
PRIMARY:  DANIEL  J  HEWETT,  (CDRH, OCER)
ANSI Board Committee on Conformity Assessment (BCCA)      
ANSI Board of Directors      
ANSI Executive Standards Council      
ANSI Government Member Council      
PRIMARY:  CAROL  L  HERMAN,  (CDRH, OSEL)
ANSI International Conformity Assessment Committee (ICAC)      
ANSI ISO Council (AIC)      
PRIMARY:  CAROL  L  HERMAN,  (CDRH, OSEL)
ANSI IT2 Image Evaluation IT2-31 X-Ray Image Evaluation    
PRIMARY:  WALID  G  MOURAD,  (CDRH, OCER)
ANSI Medical Device Standards Board (MDSB)      
ANSI

N 43 Radiation protection from equipment for nonmedical radiation applications      
PRIMARY:  DANIEL F H    KASSIDAY,  (CDRH, OHIP)
ALTERNATE:  JAMES  N  WALKER,  (CDRH, CONT)
ANSI N 43 Radiation protection from equipment for nonmedical radiation applications N 43.16 Radiation Safety Standard for X-Ray and Gamma Radiation Security Non-Intrusive Inspection Systems    
PRIMARY:  DANIEL F H    KASSIDAY,  (CDRH, OHIP)
ALTERNATE:  JAMES  N  WALKER,  (CDRH, CONT)
ANSI N 43 Radiation protection from equipment for nonmedical radiation applications N 43.17 Radiation Safety for Personnel Security Screening Systems Using IR    
PRIMARY:  DANIEL F H    KASSIDAY,  (CDRH, OHIP)
ALTERNATE:  JAMES  N  WALKER,  (CDRH, CONT)
ANSI N 44 Equipment and Materials for Medical Radiation Applications      
PRIMARY:  SANKAR  P  BASU,  (CDRH, ODE)
ANSI U.S. National Committee to IEC      
PRIMARY:  BRIAN  J  FITZGERALD,  (CDRH, OSEL)
ANSI Z 080 Ophthalmic Standards      
PRIMARY:  DON    CALOGERO,  (CDRH, ODE)
ALTERNATE:  ROBERT  H  JAMES,  (CDRH, OSEL)
ANSI Z 080 Ophthalmic Standards Subcommittee 1 Prescription Spectacle Lenses WG 1 Spectacle Lenses Z80.1 (active)  
ANSI

Z 080 Ophthalmic Standards Subcommittee 2 Sunglasses & Fashion Eyewear WG 1 Sunglasses Z80.3 (active)  
TECH EXPERT:  GENE  N  HILMANTEL,  (CDRH, ODE)
ALTERNATE:  ROBERT  H  JAMES,  (CDRH, OSEL)
ANSI Z 080 Ophthalmic Standards Subcommittee 3 Spectacle Frames WG 1 Frames Z80.5 (active)  
ANSI Z 080 Ophthalmic Standards Subcommittee 4 Medical Ophthalmic Devices WG 1 Intraocular Lenses Z80.7 (active)  
ALTERNATE:  KESIA  Y  ALEXANDER,  (CDRH, ODE)
PRIMARY:  DON    CALOGERO,  (CDRH, ODE)
TECH EXPERT:  ROBERT  W  FAALAND,  (CDRH, OSEL)
ANSI

Z 080 Ophthalmic Standards Subcommittee 4 Medical Ophthalmic Devices WG 2 Laser Systems Z80.11 (active)  
ALTERNATE:  SHERYL  L  BERMAN,  (CDRH, ODE)
ALTERNATE:  BRUCE  A  DRUM,  (CDRH, ODE)
PRIMARY:  MALVINA  B  EYDELMAN,  (CDRH, ODE)
ALTERNATE:  ROBERT  W  FAALAND,  (CDRH, OSEL)
ANSI Z 080 Ophthalmic Standards Subcommittee 4 Medical Ophthalmic Devices WG 3 Multifocal IOLS Z80.12 (active)  
ALTERNATE:  SHERYL  L  BERMAN,  (CDRH, ODE)
PRIMARY:  DON    CALOGERO,  (CDRH, ODE)
ALTERNATE:  ROBERT  W  FAALAND,  (CDRH, OSEL)
ANSI Z 080 Ophthalmic Standards Subcommittee 4 Medical Ophthalmic Devices WG 4 Phakic IOLS Z80.13 (active)  
PRIMARY:  DON    CALOGERO,  (CDRH, ODE)
ALTERNATE:  MALVINA  B  EYDELMAN,  (CDRH, ODE)
TECH EXPERT:  ROBERT  W  FAALAND,  (CDRH, OSEL)
ALTERNATE:  GENE  N  HILMANTEL,  (CDRH, ODE)
ANSI Z 080 Ophthalmic Standards Subcommittee 4 Medical Ophthalmic Devices WG 6 Operating Microscopes Z80.15 (inactive)  
TECH EXPERT:  SHARON  A  MILLER,  (CDRH, OSEL)
PRIMARY:  DEXIU    SHI,  (CDRH, ODE)
ANSI Z 080 Ophthalmic Standards Subcommittee 4 Medical Ophthalmic Devices WG 7 Endoilluminators Z80.19 (inactive)  
PRIMARY:  SHARON  A  MILLER,  (CDRH, OSEL)
ANSI Z 080 Ophthalmic Standards Subcommittee 4 Medical Ophthalmic Devices WG 8 Glaucoma Shunts Z80.27 (inactive)  
PRIMARY:  KESIA  Y  ALEXANDER,  (CDRH, ODE)
TECH EXPERT:  KIMBERLY  E  BROWN,  (CDRH, ODE)
TECH EXPERT:  BRADLEY  S  CUNNINGHAM,  (CDRH, ODE)
ANSI Z 080 Ophthalmic Standards Subcommittee 4 Medical Ophthalmic Devices WG 9 Accomodative IOLS Z80.29 (active)  
TECH EXPERT:  KESIA  Y  ALEXANDER,  (CDRH, ODE)
ALTERNATE:  SHERYL  L  BERMAN,  (CDRH, ODE)
TECH EXPERT:  DON    CALOGERO,  (CDRH, ODE)
TECH EXPERT:  BRUCE  A  DRUM,  (CDRH, ODE)
TECH EXPERT:  ROBERT  W  FAALAND,  (CDRH, OSEL)
PRIMARY:  GENE  N  HILMANTEL,  (CDRH, ODE)
ANSI Z 080 Ophthalmic Standards Subcommittee 4 Medical Ophthalmic Devices WG10 Toric IOLS Z80.30 (active)  
ALTERNATE:  SHERYL  L  BERMAN,  (CDRH, ODE)
PRIMARY:  DON    CALOGERO,  (CDRH, ODE)
TECH EXPERT:  ROBERT  W  FAALAND,  (CDRH, OSEL)
TECH EXPERT:  GENE  N  HILMANTEL,  (CDRH, ODE)
ANSI Z 080 Ophthalmic Standards Subcommittee 5 Low Vision Devices WG 1 Low Vision Devices Z80.9 (inactive)  
PRIMARY:  BERNARD  P  LEPRI,  (CDRH, ODE)
ANSI Z 080 Ophthalmic Standards Subcommittee 6 Ophthalmic Instruments WG 1 Tonometers Z80.10 (active)  
TECH EXPERT:  SHERYL  L  BERMAN,  (CDRH, ODE)
PRIMARY:  BRUCE  A  DRUM,  (CDRH, ODE)
TECH EXPERT:  GENE  N  HILMANTEL,  (CDRH, ODE)
ALTERNATE:  ROBERT  H  JAMES,  (CDRH, OSEL)
ANSI Z 080 Ophthalmic Standards Subcommittee 6 Ophthalmic Instruments WG 2 Visual Acuity Charts Z80.21 (active)  
TECH EXPERT:  SHERYL  L  BERMAN,  (CDRH, ODE)
PRIMARY:  BRUCE  A  DRUM,  (CDRH, ODE)
TECH EXPERT:  GENE  N  HILMANTEL,  (CDRH, ODE)
ALTERNATE:  ROBERT  H  JAMES,  (CDRH, OSEL)
ANSI Z 080 Ophthalmic Standards Subcommittee 6 Ophthalmic Instruments WG 3 Corneal Topography Z80.23 (active)  
TECH EXPERT:  SHERYL  L  BERMAN,  (CDRH, ODE)
PRIMARY:  BRUCE  A  DRUM,  (CDRH, ODE)
TECH EXPERT:  GENE  N  HILMANTEL,  (CDRH, ODE)
ALTERNATE:  ROBERT  H  JAMES,  (CDRH, OSEL)
ANSI Z 080 Ophthalmic Standards Subcommittee 6 Ophthalmic Instruments WG 4 Focimeters Z80.17 (active)  
TECH EXPERT:  SHERYL  L  BERMAN,  (CDRH, ODE)
PRIMARY:  BRUCE  A  DRUM,  (CDRH, ODE)
TECH EXPERT:  GENE  N  HILMANTEL,  (CDRH, ODE)
ALTERNATE:  ROBERT  H  JAMES,  (CDRH, OSEL)
ANSI Z 080 Ophthalmic Standards Subcommittee 6 Ophthalmic Instruments WG 5 Method for Reporting Optical Aberrations of Eyes Z80.28 (active)  
TECH EXPERT:  SHERYL  L  BERMAN,  (CDRH, ODE)
PRIMARY:  BRUCE  A  DRUM,  (CDRH, ODE)
TECH EXPERT:  GENE  N  HILMANTEL,  (CDRH, ODE)
ALTERNATE:  ROBERT  H  JAMES,  (CDRH, OSEL)
ANSI Z 080 Ophthalmic Standards Subcommittee 7 Contact Lenses WG 1 Contact Lenses Z80.20 (active)  
TECH EXPERT:  CHANDRAMAL    GHOSH,  (CDRH, ODE)
ALTERNATE:  GENE  N  HILMANTEL,  (CDRH, ODE)
TECH EXPERT:  JOSEPH  C  HUTTER,  (CDRH, OSEL)
TECH EXPERT:  BERNARD  P  LEPRI,  (CDRH, ODE)
TECH EXPERT:  MARC    ROBBOY,  (CDRH, ODE)
TECH EXPERT:  JAMES  F  SAVIOLA,  (CDRH, ODE)
TECH EXPERT:  MYRA  K  SMITH,  (CDRH, ODE)
PRIMARY:  KAREN  F  WARBURTON,  (CDRH, ODE)
ANSI Z 080 Ophthalmic Standards Subcommittee 7 Contact Lenses WG 2 Contact Lens Care Products Z80.18 (active)  
ALTERNATE:  GENE  N  HILMANTEL,  (CDRH, ODE)
TECH EXPERT:  JOSEPH  C  HUTTER,  (CDRH, OSEL)
TECH EXPERT:  BERNARD  P  LEPRI,  (CDRH, ODE)
TECH EXPERT:  MARC    ROBBOY,  (CDRH, ODE)
TECH EXPERT:  JAMES  F  SAVIOLA,  (CDRH, ODE)
TECH EXPERT:  MYRA  K  SMITH,  (CDRH, ODE)
PRIMARY:  KAREN  F  WARBURTON,  (CDRH, ODE)
ANSI Z 080 Ophthalmic Standards Subcommittee 8 Information Interchange WG 1 Information Interchange for Instruments Z80.26 (active)  
ANSI Z 080 Ophthalmic Standards Subcommittee 8 Information Interchange WG 2 Fundamental Standards Z80.25 (active)  
ANSI

Z 080 Ophthalmic Standards Subcommittee 8 Information Interchange WG 3 Information Interchange for Equipment Z80.24 (active)  
ANSI

Z 136 Safe Use of Lasers Committee      
ALTERNATE:  ROBERT  W  FAALAND,  (CDRH, OSEL)
PRIMARY:  RICHARD  P  FELTEN,  (CDRH, ODE)
ANSI Z 136 Safe Use of Lasers Committee Z 136/SSC-01 Safe Use of Lasers    
ALTERNATE:  ROBERT  W  FAALAND,  (CDRH, OSEL)
PRIMARY:  RICHARD  P  FELTEN,  (CDRH, ODE)
ANSI Z 136 Safe Use of Lasers Committee Z 136/SSC-02 Safe Use of Lasers in Telecommunications    
PRIMARY:  ROBERT  W  FAALAND,  (CDRH, OSEL)
ALTERNATE:  RICHARD  P  FELTEN,  (CDRH, ODE)
ANSI

Z 136 Safe Use of Lasers Committee Z 136/SSC-03 Laser Safety in Health Care Facilities    
ALTERNATE:  ROBERT  W  FAALAND,  (CDRH, OSEL)
PRIMARY:  RICHARD  P  FELTEN,  (CDRH, ODE)
ANSI Z 136 Safe Use of Lasers Committee Z 136/SSC-04 Laser Measurements    
PRIMARY:  ROBERT  W  FAALAND,  (CDRH, OSEL)
ALTERNATE:  RICHARD  P  FELTEN,  (CDRH, ODE)
ANSI Z 136 Safe Use of Lasers Committee Z 136/SSC-05 Laser Safety in Educational Facilities    
PRIMARY:  ROBERT  W  FAALAND,  (CDRH, OSEL)
ALTERNATE:  RICHARD  P  FELTEN,  (CDRH, ODE)
ANSI Z 136 Safe Use of Lasers Committee Z 136/SSC-06 Outdoor Lasers    
PRIMARY:  RICHARD  P  FELTEN,  (CDRH, ODE)
ALTERNATE:  L DALE    SMITH,  (CDRH, OC)
ANSI Z 136 Safe Use of Lasers Committee Z 136/SSC-07 Laser Eye Protection and Barriers    
PRIMARY:  ROBERT  W  FAALAND,  (CDRH, OSEL)
ALTERNATE:  RICHARD  P  FELTEN,  (CDRH, ODE)
ANSI Z 136 Safe Use of Lasers Committee Z 136/SSC-08 Laser Safety in Research and Testing Facilities    
PRIMARY:  ROBERT  W  FAALAND,  (CDRH, OSEL)
ALTERNATE:  RICHARD  P  FELTEN,  (CDRH, ODE)
ANSI Z 136 Safe Use of Lasers Committee Z 136/SSC-09 Laser Safety in Manufacturing Facilities    
PRIMARY:  ROBERT  W  FAALAND,  (CDRH, OSEL)
ALTERNATE:  RICHARD  P  FELTEN,  (CDRH, ODE)
ANSI Z 136 Safe Use of Lasers Committee Z 136/SSC-10 Laser Safety in Entertainment, Displays and Exhibitions    
PRIMARY:  RICHARD  P  FELTEN,  (CDRH, ODE)
ALTERNATE:  L DALE    SMITH,  (CDRH, OC)
ANSI

Z 311 Photobiological Safety of Lamps and Lighting Systems Subcommittee      
ALTERNATE:  EVERETTE  T  BEERS,  (CDRH, ODE)
PRIMARY:  SHARON  A  MILLER,  (CDRH, OSEL)
ASME Pressure Vessel for Human Occupancy (PVHO) Committee Subcommittee on Medical Hyperbaric Chambers    
PRIMARY:  CHRISTY  L  FOREMAN,  (CDRH, OC)
ASQC Z1 Applications of Statistical Methods in Process Management      
PRIMARY:  RONG    TANG,  (CDRH, OSB)
ASTM Board Committee on Standards (COS)      
PRIMARY:  JOHN  S  GOODE,  (CDRH, ODE)
ASTM Board of Directors      
PRIMARY:  DONALD  E  MARLOWE,  (OC, OSHC)
ASTM

D11 Rubber D11.40 Consumer Rubber Products    
PRIMARY:  CHIU  S  LIN,  (CDRH, ODE)
ALTERNATE:  DONNA  L  WALSH,  (CDRH, OSEL)
ASTM

D11 Rubber D11.40 Consumer Rubber Products D11.40.01 Condoms TG  
ALTERNATE:  LESLEY  N  KERR,  (ORA, NE-FO)
PRIMARY:  COLIN  M  POLLARD,  (CDRH, ODE)
ASTM D11 Rubber D11.40 Consumer Rubber Products D11.40.01 Condoms TG Lubricant/Latex Compatibility WG
ASTM

D11 Rubber D11.40 Consumer Rubber Products D11.40.02 Glove Durability TG  
ALTERNATE:  TERRELL  A  CUNNINGHAM,  (CDRH, ODE)
PRIMARY:  DONNA  L  WALSH,  (CDRH, OSEL)
ASTM D11 Rubber D11.40 Consumer Rubber Products D11.40.03 Glove Expiration Dating Guidance TG  
PRIMARY:  DONNA  L  WALSH,  (CDRH, OSEL)
ASTM D11 Rubber D11.40 Consumer Rubber Products D11.40.04 ELISA TG  
PRIMARY:  ANNE  D  LUCAS,  (CDRH, OSEL)
ASTM D11 Rubber D11.40 Consumer Rubber Products D11.40.06 Latex Chemical Sensitivity TG  
ALTERNATE:  GEETHA  C  JAYAN,  (ODE, DAGID)
PRIMARY:  ANNE  D  LUCAS,  (CDRH, OSEL)
ASTM D11 Rubber D11.40 Consumer Rubber Products D11.40.08 IEMA TG  
ALTERNATE:  ANNE  D  LUCAS,  (CDRH, OSEL)
PRIMARY:  MELVIN  E  STRATMEYER,  (CDRH, OSEL)
ASTM D11 Rubber D11.40 Consumer Rubber Products D11.40.09 Chemotherapy Gloves TG  
PRIMARY:  TERRELL  A  CUNNINGHAM,  (CDRH, ODE)
ASTM D11 Rubber D11.40 Consumer Rubber Products D11.40.10 Medical Glove Selection Guide TG  
PRIMARY:  TERRELL  A  CUNNINGHAM,  (CDRH, ODE)
ASTM

D11 Rubber D11.40 Consumer Rubber Products D11.40.12 Medical Glove TG  
PRIMARY:  CHIU  S  LIN,  (CDRH, ODE)
ALTERNATE:  DONNA  L  WALSH,  (CDRH, OSEL)
ASTM D11 Rubber D11.40 Consumer Rubber Products D11.40.12 Medical Glove TG Maximum Powder Working Group
ALTERNATE:  MARIA  P  CHAPUT,  (ORA, NE-FO)
PRIMARY:  CHIU  S  LIN,  (CDRH, ODE)
ASTM D11 Rubber D11.40 Consumer Rubber Products D11.40.14 Radiation Attenuation Medical Glove TG  
PRIMARY:  TERRELL  A  CUNNINGHAM,  (CDRH, ODE)
ASTM D11 Rubber D11.40 Consumer Rubber Products D11.40.18 Detection of Holes in Medical Gloves  
ALTERNATE:  MARIA  P  CHAPUT,  (ORA, NE-FO)
PRIMARY:  TERRELL  A  CUNNINGHAM,  (CDRH, ODE)
ASTM

E10 Nuclear Technology and Applications E10.01 Dosimetry for Radiation Processing    
ALTERNATE:  KIM  M  MOREHOUSE,  (CFSAN, ORS)
PRIMARY:  PATRICK  B  WEIXEL,  (CDRH, OC)
ASTM

E20 Temperature Measurement E20.08 Medical Thermometry    
PRIMARY:  WILLIAM  M  BURDICK,  (CDRH, ODE)
ASTM E31 Healthcare Informatics      
ALTERNATE:  ALBERTO    GUTIEREZ,  (CDRH, OIVD)
PRIMARY:  CLARA  A  SLIVA,  (CBER, OCBQ)
ASTM E31 Healthcare Informatics E31.13 Clinical Laboratory Information Management    
PRIMARY:  CLARA  A  SLIVA,  (CBER, OCBQ)
ASTM E48 Biotechnology      
PRIMARY:  AVRAHAM    RASOOLY,  (CFSAN, OPDFB)
ASTM F 29 Anesthetic and Respiratory Equipment F29.90 Executive    
ASTM F02 Flexible Barrier Materials      
ALTERNATE:  SRILEKHA  S  DAS,  (CDRH, OSEL)
PRIMARY:  PATRICK  B  WEIXEL,  (CDRH, OC)
ASTM F02 Flexible Barrier Materials F02.60 Medical Packaging    
ALTERNATE:  STEVEN  E  TURTIL,  (CDRH, ODE)
PRIMARY:  PATRICK  B  WEIXEL,  (CDRH, OC)
ASTM

F04 Medical and Surgical Materials and Devices      
ALTERNATE:  KEITH  E  FOY,  (CDRH, ODE)
PRIMARY:  MARK  N  MELKERSON,  (CDRH, ODE)
ASTM

F04 Medical and Surgical Materials and Devices F04.05 Computer Assisted Orthopaedic Surgical Systems    
ALTERNATE:  LONG  H  CHEN,  (CDRH, ODE)
PRIMARY:  DWIGHT    YEN,  (CDRH, ODE)
ASTM

F04 Medical and Surgical Materials and Devices F04.11 Polymeric Materials    
PRIMARY:  HANY  W  DEMIAN,  (CDRH, ODE)
ALTERNATE:  JOHN  S  GOODE,  (CDRH, ODE)
ASTM F04 Medical and Surgical Materials and Devices F04.11 Polymeric Materials F04.11.04 Poly-L-Lactic Acid (PLLA)  
PRIMARY:  HANY  W  DEMIAN,  (CDRH, ODE)
ALTERNATE:  JOHN  S  GOODE,  (CDRH, ODE)
ASTM F04 Medical and Surgical Materials and Devices F04.11 Polymeric Materials F04.11.06 Bioabsorable Polymer-Degradation Test Methods  
PRIMARY:  HANY  W  DEMIAN,  (CDRH, ODE)
ALTERNATE:  JOHN  S  GOODE,  (CDRH, ODE)
ASTM F04 Medical and Surgical Materials and Devices F04.11 Polymeric Materials F04.11.07 Rev F 451 Acrylic Bone Cement  
PRIMARY:  HANY  W  DEMIAN,  (CDRH, ODE)
ALTERNATE:  JOHN  S  GOODE,  (CDRH, ODE)
ASTM F04 Medical and Surgical Materials and Devices F04.11 Polymeric Materials F04.11.08 Revision of F648 UHMWPE  
PRIMARY:  HANY  W  DEMIAN,  (CDRH, ODE)
ALTERNATE:  JOHN  S  GOODE,  (CDRH, ODE)
ASTM

F04 Medical and Surgical Materials and Devices F04.12 Metallurgical Materials    
ALTERNATE:  DANIEL  C  CLUPPER,  (CDRH, ODE)
ALTERNATE:  DANIEL  C  CLUPPER,  (CDRH, ODE)
PRIMARY:  DAVID  M  SAYLOR,  (CDRH, OSEL)
ASTM

F04 Medical and Surgical Materials and Devices F04.13 Ceramic Materials    
PRIMARY:  PETER  G  ALLEN,  (CDRH, ODE)
ALTERNATE:  ERIN  I  KEITH,  (CDRH, OC)
ASTM F04 Medical and Surgical Materials and Devices F04.13 Ceramic Materials F04.13.04 Rev F 603-Polycrystalline Alumina  
PRIMARY:  PETER  G  ALLEN,  (CDRH, ODE)
ASTM F04 Medical and Surgical Materials and Devices F04.13 Ceramic Materials F04.13.05 CPC Crystalline Characterization  
PRIMARY:  PETER  G  ALLEN,  (CDRH, ODE)
ASTM

F04 Medical and Surgical Materials and Devices F04.15 Material Test Methods    
ALTERNATE:  HANY  W  DEMIAN,  (CDRH, ODE)
PRIMARY:  TERRY  O  WOODS,  (CDRH, OSEL)
ASTM F04 Medical and Surgical Materials and Devices F04.15 Material Test Methods F04.15.08 Abrasion of Coatings  
PRIMARY:  PETER  G  ALLEN,  (CDRH, ODE)
ASTM F04 Medical and Surgical Materials and Devices F04.15 Material Test Methods F04.15.11 MR Standards  
ALTERNATE:  WOLFGANG    KAINZ,  (CDRH, OSEL)
PRIMARY:  TERRY  O  WOODS,  (CDRH, OSEL)
ASTM

F04 Medical and Surgical Materials and Devices F04.16 Biocompatibility Test Methods    
PRIMARY:  MELVIN  E  STRATMEYER,  (CDRH, OSEL)
ASTM F04 Medical and Surgical Materials and Devices F04.16 Biocompatibility Test Methods F04.16.01 Biological Response to Particle Debris  
PRIMARY:  VICTORIA  M  HITCHINS,  (CDRH, OSEL)
ASTM F04 Medical and Surgical Materials and Devices F04.16 Biocompatibility Test Methods F04.16.05 Recovery of Foreign Particles from Tissue  
PRIMARY:  VICTORIA  M  HITCHINS,  (CDRH, OSEL)
ASTM F04 Medical and Surgical Materials and Devices F04.16 Biocompatibility Test Methods F04.16.08 Immunological Testing  
PRIMARY:  JOHN  J  LANGONE,  (CDRH, OSEL)
ALTERNATE:  DANIEL  B  LYLE,  (CDRH, OSEL)