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Insider Solutions: Device Database Can Help Pharma
Standards data is helpful, but FDA needs to apply its information across the board. This article contains bonus online-exclusive material.


Pharmaceutical Technology
Volume 33, Issue 4

Organizations Monitored by the Center for Devices and Radiological Health

AAMI: Association for the Advancement of Medical Instrumentation

ADA: American Dental Association

AIUM: American Institute of Ultrasound in Medicine

ANSI: American National Standards Institute

AOAC: AOAC International

AS: Standards Australia

ASA: Acoustical Society of America

ASME: American Society of Mechanical Engineers

ASQ: American Society for Quality

ASTM: ASTM International

CEN: European Committee for Standardization

CGA: Compressed Gas Associated, Inc.

CLSI: Clinical Laboratory Standards Institute

ESD: Electrostatic Discharge Association

IEC: International Electrotechnical Commission

IEEE: Institute of Electrical and Electronic Engineers

IESNA: Illuminating Engineering Society of North America

ISO: International Organization for Standardization

NCCLS: National Committee for Clinical Laboratory Standards

NEMA: National Electrical Manufacturers Association

NFPA: National Fire Protection Association

RESNA: Rehabilitation Engineering and Assistive Technology of North America

UL: Underwriters Laboratories, Inc.

USP: United States Pharmacopeial Convention, Inc.

Check out the following citations to obtain more information on the agency's participation in standards organizations:

1) OMB Circular A-119 (http://standards.gov/standards_gov/a119.cfm).

2) FDA Policy Statement: Participation in the Development and Use of Voluntary Standards: http://www.fda.gov/oc/guidance/voluntarystandards.html.

3) 21 CFR 10.95 Participation in outside standard-setting activities.

Susan J. Schniepp is vice-president of quality assurance at Javelin Pharmaceuticals, 125 Cambridge Park Drive, Cambridge, MA 02140, tel. 617.499.4709,


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