DIRECTORY OF ORGANIZATIONS AND ASSOCIATIONS

Academy of Dental Materials
3302 Gaston Ave., Dallas, TX 75246; 214/828-8378, fax 214/874-4503
Objectives are to provide a forum for the expression of opinions related to the physical and chemical properties, biological interaction, clinical applications, and techniques of utilization of materials in the field of dentistry and to encourage research in the development of materials applicable to the art and science of dentistry.

Adhesive and Sealant Council, Inc.
1627 K St. N.W., Ste. 1000, Washington, DC 20006; 202/452-1500, fax 202/452-1501
A nonprofit, international trade association incorporated in 1958 for the purpose of providing opportunities for dialogue, education, advancement, and improvement of all aspects of the adhesive and sealant industry. Offers semiannual conventions, technical short courses, government relations, statistics, and publications.

American Association for Clinical Chemistry
2101 L St. N.W., Washington, DC 20037-1526; 202/857-0717, 800/892-1400, fax 202/887-5093
A nonprofit, international educational organization of more than 11,000 members with a common interest in clinical laboratory science. Members specialize in fields such as clinical chemistry, biochemistry and immunology, molecular pathology, medical technology, clinical pathology, toxicology, and laboratory management. The association publishes books, a news magazine, and a journal; holds a national meeting; offers educational programs; and is involved in government and regulatory affairs.

American Dental Trade Association
4222 King St. W., Alexandria, VA 22302-1597; 703/379-7755, fax 703/931-9429
The oldest and largest trade group representing the dental industry in the United States, with international ties. Members include distributors, laboratories, and manufacturers of supplies and equipment used in dental offices, laboratories, and schools.

American Electronics Association
1225 Eye St. N.W., Ste. 950, Washington, DC 20005; 202/682-9110, fax 202/682-9111
Dedicated to strengthening the U.S. electronics and information technology industry's global competitiveness. The trade group, which represents some 3000 companies, offers members opportunities such as financial conferences, management programs, compensation surveys, group advantage member services, an industry statistics program, local council networking, and government relations programs. Its public affairs staff represents the association and industry in such areas as taxation, trade, education, government procurements, and the environment.

American Institute for Medical and Biological Engineering
1901 Pennsylvania Ave. N.W., Ste. 401, Washington, DC 20006; 202/496-9660, fax 202/466-8489
AIMBE was formed in 1991 with the sponsorship of the National Science Foundation to assist various constituencies of the medical and biological engineering community on issues of mutual interest. The institute offers a forum for catalyzing broad involvement of engineers, representation of medical and biological engineering on issues of national interest, and research on policy issues related to the development and evaluation of the appropriate use of technology in medicine and biology. The organization also offers workshops and courses designed to educate the professional community and the public at large. Fifteen scientific societies representing the full spectrum of bioengineering research and education in the United States are full members of AIMBE.

American National Standards Institute
11 W. 42nd St., New York, NY 10036; 212/642-4900, fax 212/398-0023
A private nonprofit membership organization that coordinates the U.S. voluntary standards system, bringing together interests from the private and public sectors to develop voluntary standards for a wide array of U.S. industries. The institute's membership includes approximately 1300 national and international companies, 32 government agencies, 24 institutions, and 261 professional, technical, trade, labor, and consumer organizations. ANSI is the official U.S. member body to the world's leading standards bodies--the International Organization for Standardization and the International Electrotechnical Commission--via the U.S. National Committee.

American Society for Clinical Laboratory Science
7910 Woodmont Ave., Ste. 530, Bethesda, MD 20814; 301/657-2768, fax 301/657-2909
A large nonregistry professional association for nonphysician clinical laboratory professionals. Its 20,000 members include hematologists, phlebotomists, immunologists, immunohematologists, clinical chemists, microbiologists, managers, and educators.

American Society for Testing and Materials
100 Barr Harbor Dr., West Conshohocken, PA 19428-2959; 610/832-9500, fax 610/832-9555
A primary source of voluntary standards for materials, products, systems, and services. The society's 32,000 members contribute their time and expertise to the development and maintenance of standards and related technical information. More than 10,000 standards are published in the 71-volume Annual Book of ASTM Standards.

American Vacuum Society
120 Wall St., 32nd Fl., New York, NY 10005; 212/248-0200, fax 212/248-0245
An interdisciplinary organization of professionals in basic research, applied research, development, manufacturing, and sales. Its technical divisions are: applied surface science, electronic materials and processing, nanometer science and technology, plasma science and technology, thin film, vacuum metallurgy, and vacuum technology. The society sponsors more than 70 short courses in addition to publishing three technical journals.

AOAC International
481 N. Frederick Ave., Ste. 500, Gaithersburg, MD 20877-2417; 301/924-7077, fax 301/924-7089
An independent association of scientists and organizations in the public and private sectors devoted to promoting methods validation and quality measurements in the analytical sciences.

ASQC (American Society for Quality Control)
P.O. Box 3005, Milwaukee, WI 53201-3005; 800/248-1946, fax 414/272-1734
Founded in 1946, the ASQC is a quality source for information on the development, promotion, and application of quality strategies and techniques. The professional, not-for-profit association serves more than 140,000 individuals and 1100 sustaining members.

The Association for Electric Motors, Their Control and Application (SMMA)
P.O. Box 378, Sherborn, MA 01770-0378; 508/655-4409, fax 508/651-3920
SMMA is the North American association, with a global focus, for electric motors, their control, and application. It serves as the principal voice of the industry and provides a forum to develop, collect, and disseminate technical and management knowledge. Current membership is 180 companies including manufacturers of motors, controls, materials, and components; media; universities; and consultants. In addition to a spring management meeting and a fall technical meeting, SMMA offers motor design courses through the SMMA Motor College.

Association for the Advancement of Medical Instrumentation
3330 Washington Blvd., Ste. 400, Arlington, VA 22201-4598; 703/525-4890, fax 703/276-0793
An alliance of engineering, medicine, nursing, industry, and government professionals united by the common goal of increasing the understanding and beneficial use of medical instrumentation. AAMI fulfills its mission through continuing education conferences, certification of health-care technical specialists, and the publication of technical documents and periodicals.

Association of Medical Diagnostics Manufacturers
Columbia Square, 555 13th St. N.W., Ste. 700W, Washington, DC 20004-1108; 202/637-6837, fax 202/637-5910
Established in 1973, AMDM is a nonprofit trade association that serves as a resource for education and information on compliance issues for member companies, and as an interface between member companies and FDA. Originally, membership was limited to manufacturers and distributors of prepared microbiological media. Today membership includes companies of all sizes that manufacture and distribute in vitro diagnostic products, including cell cultures and cell culture media, immunology and immune status test products, antigen and microbial detection products, and toxicology products.

Biomedical Marketing Association
3905 Vincennes Rd., Ste. 304, Indianapolis, IN 46268; 317/228-8067, fax 317/872-7133
A nonprofit professional organization of nearly 700 marketing and management professionals involved in marketing diagnostics and other medical products or services. The association offers seminars, an annual conference, a marketing educational conference, and presents marketing excellence awards.

California Healthcare Institute
1020 Prospect St., Ste. 310, La Jolla, CA 92037; 619/551-6677, fax 619/551-6688
A statewide public policy research and advocacy organization for California's health-care technology industry. CHI's members include medical device, biotechnology, and pharmaceutical companies, as well as public and private research institutions in California. The organization combines the strengths of these industries to advocate state and federal policies that promote scientific discovery and biomedical innovation. CHI's legislative priorities include: FDA reform, broadening state R&D tax incentives to reflect the special needs of medical device innovators, ensuring Medicare reimbursement for procedures involving investigational medical devices, and tort reform that ensures the availability of biomaterials to medical device manufacturers.

Contact Lens Manufacturers Association
4400 E. West Hwy., Ste. 33, Bethesda, MD 20814; 301/654-2229, fax 301/654-1611
Organized in 1961, CLMA is made up of contact lens laboratories and material, solution, and equipment manufacturers both in the United States and abroad. The mission of CLMA is to increase awareness and use of custom-manufactured contact lenses.

Controlled Release Society
1020 Milwaukee Ave., Ste. 235, Deerfield, IL 60015; 847/808-7071, fax 847/808-7073
European Office: c/o University of Geneva School of Pharmacy, 30 quai E.-Ansermet, CH-1211 Geneva 4, Switzerland; (41) 22 7026339; fax (41) 22 7026339
An international organization with the mission of advancing the science and technology of chemical and biological delivery systems. The society sponsors annual symposia, workshops, and short courses; publishes a newsletter; and promotes education and student and local chapters.

Council on Packaging in the Environment
1255 23rd St. N.W., Ste. 850, Washington, DC 20037; 202/331-0099, fax 202/833-3636
A national coalition of consumer product companies, packaging producers, material suppliers, retailers, trade associations, and recyclers. The council was formed in recognition of the fact that in recent years packaging, as part of larger environmental issues, is of increasing concern. The council acknowledges this concern and wishes to do its part in helping to resolve environmental packaging issues in the most efficient and responsible manner possible.

ECRI
5200 Butler Pike, Plymouth Meeting, PA 19462-1298; 610/825-6000, fax 610/834-1275
ECRI, a nonprofit health services research agency and a collaborating center of the World Health Organization, provides information to the health-care community to support safe and cost-effective patient care. ECRI is world's largest independent evaluator of medical devices and maintains numerous databases on medical technologies. ECRI publishes the Health Devices Sourcebook, an annual directory of medical device manufacturers and equipment, and the Healthcare Product Comparison System on CD-ROM, an international database of capital medical equipment, including brand-name product specifications and overviews of various technologies.

Edison Welding Institute
1250 Arthur E. Adams Dr., Columbus, OH 43221; 614/688-5000, fax 614/688-5001
EWI is a leading engineering organization with over 160 engineering, technical, and support staff members with expertise in virtually every welding and joining technology available today for joining metals, ceramics, and plastics. EWI operates as a nonprofit industrial consortium, working with over 340 member companies to provide applied research, consultancy, training, and general technical support. Medical manufacturers have used EWI's expertise to assess the weldability of nitinol; develop processes for refractory metals such as platinum, platinum-iridium, tungsten, and molybdenum; join dissimilar materials such as ceramics to stainless steel; or assess the seal integrity of plastic materials.

Electromagnetic Energy Association
1255 23rd St. N.W., Ste. 850, Washington, DC 20037; 202/452-1070, fax 202/833-3636
A nonprofit association of manufacturers and users of electrical and electronic systems. The association develops educational programs, sponsors research, and advocates rational, science-based exposure standards on the production and use of nonionizing electromagnetic energy.

Electronic Industries Association
2500 Wilson Blvd., Arlington, VA 22201; 703/907-7500, fax 703/907-7501
A national trade organization representing U.S. electronic manufacturers. Committed to the competitiveness of the American producer, EIA represents the entire spectrum of companies involved in the manufacture of electronic components, parts systems, and equipment for communications, industrial, government, and consumer uses.

Electrostatic Discharge Association
7902 Turin Rd., Ste. 4, Rome, NY 13440-2069; 315/339-6937, fax 315/339-6793
A professional voluntary association dedicated to advancing the theory and practice of electrostatic discharge (ESD) avoidance. From an initial emphasis on the effects of ESD on electronic components, the association is broadening its scope to include other areas such as textiles and fully assembled electronic products. The association sponsors educational activities, including symposia and regional tutorials to support research and education in ESD.

Ethylene Oxide Sterilization Association
1815 H St. N.W., Ste. 500, Washington, DC 20006-3604; 202/296-6300, fax 202/775-5929
EOSA is a trade organization for parties interested in ethylene oxide and its diverse uses. Membership is open to any interested party, but EOSA's primary focus is to service medical and pharmaceutical companies, contract ethylene oxide sterilizers, gas sterilant suppliers, related users and suppliers, and consultants to the industry. The association was formed to promote the benefits of using ethylene oxide for sterilization purposes and to represent other common interests of its members. Some of the objectives include information sharing, monitoring regulatory activities, undertaking advocacy positions, addressing proposed government regulations, and fostering reasonable regulations and truthful communications regarding ethylene oxide.

FDLI
1000 Vermont Ave. N.W., Ste. 200, Washington, DC 20005; 202/371-1420, fax 202/371-0649
Composed of more than 480 manufacturers, suppliers, law firms, consultants, and other organizations, FDLI is a nonprofit educational organization that provides a neutral forum for the exchange of views. Its mission is to promote an understanding of the laws, regulations, and policies affecting the public health aspects of foods, drugs, cosmetics, medical devices, biological products, and veterinary medical products. This is done through seminars, publications, scholarships, and the support of food and drug law courses. The organization, once known as the Food and Drug Law Institute, now uses FDLI as its complete name.

Flexible Packaging Association
1090 Vermont Ave. N.W., Ste. 500, Washington, DC 20005; 202/842-3880, fax 202/842-3841
Represents companies that convert or supply flexible packaging made of paper, plastic film, aluminum foil, or any combination of those materials. The association produces statistics on industry growth, imports and exports, operating ratios and compensation; develops standards and guides on technical specification, sterilization packaging, and bar code scanning; issues legislative and regulatory alerts and reports, curriculum guides for public schools, and a newsletter with pertinent industry developments; and sponsors an annual awards competition for the best flexible packaging.

Georgia Biomedical Partnership, Inc.
2800 Nations Bank Plaza, 600 Peachtree St., P.O. Box 54151, Atlanta, GA 30308-4151; 404/817-5917, fax 404/817-4345
A nonprofit membership organization devoted to the advancement of biomedical technology and healthcare-related economic development, technology transfer, and strengthening of the state's biomedical infrastructure. Membership is composed of biomedical companies, research institutions, corporate service providers, and individuals committed to the promotion, support, and development of the biomedical technology industry in Georgia.

Health Care Industries Association
P.O. Box 89, Niagara Square Station, Buffalo, NY 14201-0089; 716/856-8111, fax 716/856-1744
A not-for-profit membership organization composed of many of western New York's health-related companies and organizations. HCIA brings together manufacturers, distributors, providers, suppliers, and members from universities and hospitals. It is dedicated to promoting this sector and its economic growth by facilitating networking, providing support services, and marketing the region nationally and internationally.

Health Industry Business Communications Council
5110 N. 40th St., Ste. 250, Phoenix, AZ 85018; 602/381-1091, fax 602/381-1093
An industry-sponsored and -supported nonprofit organization, the council's primary function is to facilitate electronic communications by developing appropriate standards for information exchange among all health-care trading partners.

The Health Industry Council of the Dallas­Fort Worth Region
1460 Post & Paddock, Grand Prairie, TX 75050; 972/606-0510, fax 972/641-5719
A nonprofit association founded to encourage health industry growth in the Dallas­Fort Worth region. The council gathers health industry data about the area, promotes industry conferences and conventions, and facilitates interaction among members of the health-care community.

Health Industry Distributors Association
66 Canal Center Plaza, Ste. 520, Alexandria, VA 22314-1538; 703/549-4432, fax 703/549-6495
National business trade association representing medical product distributors and home-health-care providers. The association's wholesale and retail members serve the nation's home-care, hospital, long-term-care, and physician/alternate-care markets.

Health Industry Manufacturers Association
1200 G St., Ste. 400, Washington, DC 20005; 202/783-8700, fax 202/783-8750
HIMA is a Washington, DC­based trade association and the largest medical technology association in the world, representing more than 700 manufacturers of medical devices, diagnostic products, and medical information systems. HIMA's members manufacture nearly 90% of the more than $51 billion of health-care technology products purchased annually in the United States, and nearly 60% of the $120 billion purchased annually around the world.

Health Industry Representatives Association
6535 S. Dayton St., Ste. 3000, Englewood, CO 80111-6135; 303/649-1622, 800/777-4474, fax 303/799-0678
A trade association of independent contractor sales representatives in the health-care industry.

Independent Medical Distributors Association
5818 Reeds Rd., Mission, KS 66202-2740; 913/262-4510, 800/398-5632, fax 913/262-0174
An association of specialized medical distributors who are engaged primarily in the sale and distribution of specialized high-technology medical supplies and equipment.

Independent Reagent Manufacturers Association
845 Ave. G E., Arlington, TX 76011; 817/640-0965, 800/433-7224, fax 817/649-2461
IRMA is a coalition of in vitro diagnostic manufacturers working together with regulatory agencies, legislators, and other trade associations to address relevant issues that affect the device industry. There are no dues associated with membership.

Indiana Medical Device Manufacturers Council, Inc.
1908 E. 64th St., South Drive, Indianapolis, IN 46220; 317/257-8558, fax 317/259-4191
Formed in 1991 as a trade association of companies and individuals involved in the manufacture of medical devices in Indiana. Composed of 41 corporate and 23 associate members, IMDMC focuses on training and education, legislative and regulatory issues, networking, and technology transfer. Meetings include four international business briefings, four regulatory/legislative roundtables, and four presentations on industry topics each year. IMDMC produces two seminars per year and a quarterly newsletter.

The Institute of Electrical and Electronics Engineers, Inc.
445 Hoes Ln., P.O. Box 1331, Piscataway, NJ 08855-1331; 908/981-0060, fax 908/981-1855
IEEE is the world's largest technical professional society. Serving the computing, electrical engineering, and electronics professions, IEEE engages in technical, educational, and professional activities that advance the theory and practice of electrotechnology, contribute to the lifelong professional and personal development of its members, and advance the profession. As scientific and technological advances are made, IEEE members transform such new knowledge into practical, safe products and procedures that enhance the quality of life. IEEE provides services and standards to serve members, the profession, and the public.

Institute of Environmental Sciences
940 E. Northwest Hwy., Mt. Prospect, IL 60056; 847/255-1561, fax 847/255-1699
An international professional organization dedicated to enhancing process and product quality through the advancement of controlled environment technologies. The institute establishes and maintains standards, recommended practices, educational programs, and communication forums. Members contribute to environmental sciences in the areas of contamination control in electronics manufacturing and pharmaceutical processes; design, testing, and evaluation of commercial and military equipment; product reliability issues associated with commercial and military systems; and computer applications in all areas of environmental science.

Institute of Packaging Professionals
481 Carlisle Dr., Herndon, VA 20170; 703/318-8970, fax 703/318-0310
IoPP is the leading individual membership organization in the packaging industry. The institute offers a full program of membership services, including technical and news publications, professional development conferences, local chapter activities, an annual packaging design competition, and the only professional certification program in the packaging field.

International Society for Optical Engineering (SPIE)
P.O. Box 10, Bellingham, WA 98227-0100; 360/676-3290, fax 360/647-1445
An international technical society dedicated to advancing engineering, scientific, and commercial applications of optical, photonic, imaging, electronic, and optoelectronic technologies. Its members are engineers, scientists, and users interested in the development and reduction to practice of these technologies. SPIE provides the means for communicating new developments and applications information to the engineering, scientific, and user communities through its publications, symposia, education programs, and on-line electronic information services.

ISHM, The International Society for Hybrid Microelectronics
1850 Centennial Park Dr., Ste. 105, Reston, VA 20191-1517; 703/758-1060, fax 703/758-1066
ISHM, the International Society of Hybrid Microelectronics, will merge in January 1997 with the International Electronics Packaging Society to form the new International Microelectronic and Packaging Society, which will have more than 5500 members worldwide. Member benefits include a free comprehensive guide to industry products and services, discounts on attendance at symposia and lectures, membership in a local chapter, and a free subscription to our quarterly publication, the International Journal of Microcircuits & Electronic Packaging, and bimonthly publication, Advancing Microelectronics.

Joint Council of Immunohistochemical Manufacturers
P.O. Box 260051, Crestwood, MO 63126; 317/576-3854, fax 317/845-2324
An association that advocates collectively the interests of its members in regulatory, clinical, and scientific matters concerning antibodies and molecular biology reagents and related products. JCIM includes manufacturers of IVD devices employing related technology, relevant contract research organizations, and others.

Medical Alley
Travelers Express Tower, Ste. 725, 1550 Utica Ave. S., St. Louis Park, MN 55416-5307; 612/542-3077, fax 612/542-3088
A 230-member trade group whose membership includes high- and low-technology medical device and product manufacturers; those involved in health-care delivery, such as hospitals, clinics, health professionals, third-party payers, health plans, integrated service networks, research facilities, public sector representatives, and pharmaceutical companies; and companies and organizations that share in the industry's goals and concerns. Medical Alley is a collaborative forum that promotes an environment to enhance innovation in health care. The association serves as a forum for the diverse sectors of the industry to meet on common ground and offers an opportunity to connect with other industry leaders. Main areas of activity include educational/informational seminars; peer group discussions of regulatory, clinical, and reimbursement issues; legislative advocacy; and increasing international activity of members.

Medical Device Manufacturers Association
1900 K St. N.W., Ste. 300, Washington, DC 20006; 202/496-7150, fax 202/496-7756
A national trade association that represents nearly 110 independent manufacturers of medical devices, diagnostic products, and health-care information systems. MDMA seeks to improve the quality of patient care by encouraging the development of new medical technology and fostering the availability of beneficial, innovative products. To achieve these goals, MDMA represents its members' interests with regard to the laws and regulations administered by FDA and Congress and any interpretation or application of those laws and regulations. MDMA is a founding member of the National Medical Device Coalition.

Medical Devices Canada (MEDEC)
401 The West Mall, Ste. 510, Etobicoke, Ont., Canada M9C 5J5; 416/620-1915, fax 416/620-1595
Established in 1972, the association has about 100 members representing manufacturers and distributors of medical devices in Canada. MEDEC has three action groups focused on regulatory, marketing, and professional development issues.

Medical Marketing Association
74 New Montgomery, Ste. 230, San Francisco, CA 94105; 415/764-4807, 800/551-2173, fax 415/764-1023 Provides personal, professional, and educational growth opportunities for people interested in marketing medical products and services. The association encourages the exchange of ideas, promotes standards, and provides education and training to enhance the quality of medical marketing and business success. Its 1200 members are from pharmaceutical, diagnostics, and device companies, and agencies and suppliers serving them. There are 13 chapters nationwide that provide monthly educational activities.

Michigan Medical Device Manufacturers and Suppliers Association
P.O. Box 130500, Ann Arbor, MI 48113; 313/930-9787, 800/930-5698, fax 313/930-0145
MMDM&SA was formed in 1993 with the mission to promote and strengthen the medical device industry in Michigan. It sponsors training seminars and a luncheon speaker series; is active in the areas of government relations, networking, and business development; and acts as an information clearing house for matters of interest to members. It also sponsors the only statewide industry trade show every October, publishes a bimonthly association newsletter, has launched a home page on the Internet, is developing a membership directory, and works with other associations in the region to enhance the visibility of its members.

National Association for Medical Equipment Services (NAMES)
625 Slaters Ln., Ste. 200, Alexandria, VA 22314-1171; 703/836-6263, fax 703/836-6730
Formerly known as the National Association of Medical Equipment Suppliers, NAMES is the national association representing the home medical equipment services industry and rehabilitative/assistive technology industries. The association represents a diversified membership of more than 1600 home medical equipment and rehabilitation technology suppliers with some 4500 sites, more than 100 home medical equipment manufacturers, and 38 state/regional home medical equipment associations.

National Association of Manufacturers
1331 Pennsylvania Ave. N.W., Ste. 1500, North Tower, Washington, DC 20004-1790; 202/637-3000, fax 202/637-3182
The association, headquartered in Washington, DC, is the oldest and largest broad-based manufacturing association, with more than 14,000 member companies.

National Electrical Manufacturers Association
1300 N. 17th St., Ste. 1847, Rosslyn, VA 22209; 703/841-3200, fax 703/841-3300
Through its Diagnostic Imaging and Therapy Systems Division, the association lobbies and gathers information for manufacturers of medical imaging and therapy equipment. The division also works with imaging and therapy equipment manufacturers to represent their views to Congress and FDA. The division is divided into several groups (nuclear medicine, x-ray equipment, magnetic resonance imaging, ultrasound, lithotripsy, radiation therapy, and MED PAC) to provide detailed information on technological, business, and legislative development. The association is also active in developing voluntary standards for the imaging and therapy device industry.

National Fluid Power Association
3333 N. Mayfair Rd., Milwaukee, WI 53222; 414/778-3344, fax 414/778-3361
A trade association of 175 U.S. and multinational manufacturers of hydraulic and pneumatic products and systems.

National Medical Device Coalition
1900 K St. N.W., Ste. 300, Washington, DC 20006; 202/496-7150, fax 202/496-7756
NMDC is a union of 10 regional and product- specific groups dedicated to reforming FDA's product approval process.

NCCLS
940 W. Valley Rd., Ste. 1400, Wayne, PA 19087-1898; 610/688-0100, fax 610/688-0700
An organization of volunteer experts working to define procedures to improve the products and services of the patient-testing community. Members include laboratorians, clinicians, and representatives of health-care institutions, professional societies, government agencies, public health laboratories, industry, and international organizations. The organization was formerly known as the National Committee for Clinical Laboratory Standards.

Orange County Regulatory Affairs
P.O. Box 1187, Costa Mesa, CA 92628; 714/453-1715, fax 714/453-1817
A grassroots organization based in Southern California's Orange County. Members include executives from medical device companies and pharmaceutical firms, consultants, and other professionals working in the medical device industry. The organization participates as a satellite downlink site for quarterly teleconferences of FDA's Center for Devices and Radiological Health and sponsors regular meetings.

Packaging Machinery Manufacturing Institute
4350 N. Fairfax Dr., Ste. 600, Arlington, VA 22203; 703/243-8555, fax 703/243-8556
A national trade association whose more than 370 members manufacture packaging and packaging-related converting machinery in the United States.

Parenteral Drug Association
7500 Old Georgetown Rd., Ste. 620, Bethesda, MD 20814; 301/986-0293, fax 301/986-0296
A nonprofit international association of over 7000 scientists involved in the development, manufacture, quality control, and regulation of pharmaceuticals and related products. The mission of the association is education and information sharing in practical applications of pharmaceutical technology. In addition to educational conferences and courses, the association publishes technical reports, a scientific journal, and a newsletter on industry and regulatory news.

Radiological Society of North America
2021 Spring Rd., Ste. 600, Oak Brook, IL 60521; 630/571-2670, fax 630/571-7837
An association of 30,000 radiologists and physicists in medicine dedicated to education in the science of radiology.

Regulatory Affairs Professionals Society
12300 Twinbrook Pky., Ste. 350, Rockville, MD 20852; 301/770-2920, fax 301/770-2924
An international organization of regulatory professionals. Founded in 1976, the society has grown to more than 6000 members worldwide, serving individuals in the pharmaceutical, medical device, biologic, biotechnology, and related areas. The society's goals are to facilitate the exchange of ideas, to foster cooperation among regulatory professionals in industry and government, and to provide continuing education in regulatory affairs.

Semiconductor Industry Association
181 Metro Dr., Ste. 450, San Jose, CA 95110; 408/436-6600, fax 408/436-6646
Represents U.S.-based semiconductor manufacturers. The association's primary focus is on international trade, specifically unfair trade practices and increased access for U.S. products in world markets. Other activities of the association include addressing market concerns such as technology policy, occupational safety and health, environmental issues, industry statistics, government semiconductor procurement, and related issues affecting U.S. semiconductor competitiveness.

Society for Biomaterials
6518 Walker St., Ste. 150, Minneapolis, MN 55426-4244; 612/927-8108, fax 612/927-8127
A professional society that promotes advances in biomedical materials research and development through cooperative research, educational programs, clinical applications, and professional standards in the biomaterials field.

Society for Information Display
1526 Brookhollow Dr., Ste. 82, Santa Ana, CA 92705-5421; 714/545-1526, fax 714/545-1547
An international society devoted to the advancement of electronic display technology, manufacturing, and applications.

Society for the Advancement of Material and Process Engineering (SAMPE)
1161 Parkview Dr., Covina, CA 91724-3748; 818/331-0616, fax 818/332-8929
An international professional member society that provides information on new materials and processing technology via technical forums, journal publications, or books in which professionals in the field can exchange ideas and air views. The society provides a forum for scientists, engineers, and academicians.

Society of Manufacturing Engineers
One SME Dr., P.O. Box 930, Dearborn, MI 48121-0930; 313/271-1500, fax 313/271-2861
An international professional society dedicated to serving it members and the manufacturing community through the advancement of professionalism, knowledge, and learning. Founded in 1932, SME has more than 70,000 members in 70 countries and sponsors 300 chapters, districts, and regions, as well as 240 student chapters. The society offers expositions, conferences, and educational publications. Among its associations is the Association for Electronics Manufacturing, which provides educational leadership and promotes the exchange of information among electronics manufacturing professionals.

Society of Plastics Engineers
14 Fairfield Dr., Brookfield, CT 06804; 203/775-0471, fax 203/775-8490
Dedicated to helping engineers attain higher professional status through increased scientific, engineering, and technical knowledge. The society has more than 37,500 members worldwide involved in engineering, design, production and processing, research and development, consulting, marketing and sales, purchasing, education, and all levels of management.

Society of the Plastics Industry
1275 K St. N.W., Ste. 400, Washington, DC 20005; 800/774-0015 or 202/371-5235; fax back information line 800/774-4614 ext. 9555
A trade association of more than 2000 members representing all segments of the plastics industry in the United States, SPI's operating units and committees are composed of resin manufacturers, plastics processors, mold makers, and other industry-related groups and individuals. SPI was founded in 1937.

Southwest Biomedical Coalition
851 University Blvd., Ste. 200, Albuquerque, NM 87106; 505/272-7900, fax 505/272-7300
The Southwest Biomedical Coalition is a regional association of device manufacturers and related entities located in West Texas and the state of New Mexico. The organization sponsors a monthly educational meeting featuring guest speakers on technological and business issues of interest to the biomedical community. Members of the coalition include medical device manufacturers and their suppliers as well as representatives of the public health-care sector, universities and national laboratories, and the legal, banking, and finance sectors.

Surface Mount Equipment Manufacturers Association
1795 Lake Cook Rd., Ste. 205, Highland Park, IL 60035; 847/831-1002, fax 847/831-1691
A trade association with membership consisting of companies manufacturing equipment or producing software for surface-mount board production. The association holds semiannual meetings in conjunction with surface-mount technology trade shows and events, has a customer advisory council of technical leaders in the electronic manufacturing industry, issues standards and specifications papers, and produces a quarterly newsletter.

Surfaces in Biomaterials Foundation
6518 Walker St., Ste. 150, Minneapolis, MN 55426-4215; 612/915-1011, fax 612/927-8127
Brings together those who share the common goal of participating in the future of surface biomaterials research. The foundation exists to ensure sponsorship of workshops and symposia, to further the exchange of information and ideas within the surface science and biomedical communities, help in understanding of interfacial problems common to many researchers and development engineers, and provide a forum that allows interaction and dissemination of surface and interfacial information.

Underwriters Laboratories, Inc.
333 Pfingsten Rd., Northbrook, IL 60062-2096; 847/272-8800, fax 708/272-8129
1655 Scott Blvd., Santa Clara, CA 95050-4169; 408/985-2400, fax 408/296-3256
12 Laboratory Dr., Research Triangle Park, NC 27709-3995; 919/549-1400, fax 919/549-1842
1285 Walt Whitman Rd., Melville, NY 11747-3081; 516/271-6200, fax 516/421-5820
2600 N.W. Lake Rd., Camas, WA 98607; 360/817-5550, fax 360/817-6000
An independent, not-for-profit safety testing and certification organization that has evaluated products, materials, and systems in the interest of public safety since 1894. In addition to evaluating and listing products to U.S. and Canadian safety standards, UL also evaluates products, including medical equipment, and classifies them in accordance with International Electrotechnical Commission publications. UL also offers an ISO 9000 registration program. In addition, it is accredited as a third-party reviewer of certain medical devices under FDA's pilot program for the third-party review of selected 510(k) premarket submissions.

U.S.-ASEAN Council
1400 L St. N.W., Ste. 375, Washington, DC 20005-3509; 202/289-1911, fax 202/289-0519
A national membership organization representing private sector interests in ASEAN (the Association of Southeast Asian Nations--Brunei, Indonesia, Malaysia, Philippines, Singapore, Thailand, and Vietnam). The council and its corporate members are committed to promoting and expanding U.S.-ASEAN trade and investment, fostering the growth of business ties, and implementing programs that assist U.S. and ASEAN companies in identifying commercial opportunities.

Utah Life Science Industries Association
3652 West 2100 South, Salt Lake City, UT, 84120; 801/972-1715, fax 801/972-9092
ULSIA is a nonprofit organization formed to promote the general welfare of life science industries in Utah and the nation. It was created to accommodate the needs of businesses and organizations in several industry sectors, including the biotechnology, medical device, diagnostic, and health-care sectors. Its mission is to develop and promote life science industries by bringing members together in partnership to foster education at all levels; facilitate innovation, excellence, and international competitiveness in products and services; gain consensus for action; and handle matters relating to policy formation, legislation, and regulations that impact these industries.

KEY GOVERNMENT AGENCIES

Agency for Health Care Policy and Research
2101 E. Jefferson St., Rockville, MD 20852; 301/594-1364, fax 301/594-2283
The Agency for Health Care Policy and Research, a part of the Public Health Service within the U.S. Department of Health and Human Services, is the lead federal agency charged with supporting research designed to improve the quality of health care, reduce its cost, and broaden access to essential services. The agency's research brings practical, science-based information to medical practitioners and to consumers and to other health-care purchasers. AHCPR was established in December 1989, replacing the National Center for Health Services Research and Health Care Technology.

Environmental Protection Agency
Organization and Management Consulting Services, Mail Code 3603, 401 M St. S.W., Washington, DC 20460; 202/260-5000, fax 202/260-4997
The U.S. Environmental Protection Agency is dedicated to improving and preserving the quality of the national and global environment. The agency works to ensure that federal environmental laws are implemented and enforced effectively; that economic development and environmental protection are integrated in U.S. foreign and domestic policy; and that public and private decisions affecting energy, transportation, agriculture, industry, international trade, and natural resources fully integrate considerations of environmental quality.

Export-Import Bank of the United States
811 Vermont Ave. N.W., Washington, DC 20571; 202/565-3200, fax 202/565-3210
The Export-Import Bank of the United States is an independent government agency that helps finance the overseas sales of U.S. goods and services. The bank's mission is to create jobs through exports. It guarantees working capital loans for U.S. exporters and the repayment of loans by foreign purchasers of U.S. goods and services. The agency also offers export credit insurance policies to protect against political and commercial risks of a foreign buyer defaulting on payment.

Federal Trade Commission
Office of Public Affairs, 6th St. and Pennsylvania Ave. N.W., Washington, DC 20580; 202/326-2180, fax 202/326-2050
FTC promotes business competition in the United States and polices anticompetitive practices. The commission also works to prevent false advertising of consumer products through the regulation of packaging and labeling. Its work is divided into the bureaus of Consumer Protection, Competition, and Economics.

Health Care Financing Administration
Division of Professional and Business Affairs, 6325 Security Blvd., Baltimore, MD 21207; 202/690-6616, fax 202/690-7159
HCFA was created in 1977 by the Secretary of Health, Education, and Welfare to administer the Medicare program, the federal portion of the Medicaid program, and related quality assurance activities. The agency has about 4000 employees engaged in policy development, program operations, legislative analysis and liaison activities, health-care research and demonstrations, budget preparation and analysis, actuarial studies, data collection and processing, enforcement of health-care quality standards, and public information activities. HCFA provides health-care services to more than 70 million elderly, disabled, and poor Americans in the Medicare and Medicaid programs.

National Institute of Standards and Technology
Inquiries Unit, Gaithersburg, MD 20899-0001; 301/975-3058, fax 301/926-1630
As an agency of the U.S. Department of Commerce's Technology Administration, NIST's primary goal is to promote U.S. economic growth by working with industry to develop and apply technology, measurements, and standards. Its major programs are: a rigorously competitive Advanced Technology Program that provides cost-shared grants to industry for development of high-risk technologies with significant commercial potential; a grassroots Manufacturing Extension Partnership that helps small and medium-sized companies adopt new technologies; a strong laboratory effort planned and implemented in cooperation with industry and focused on measurements, standards, evaluated data, and test methods; and a highly visible quality outreach program associated with the Malcolm Baldrige National Quality Award.

Occupational Safety and Health Administration
200 Constitution Ave. N.W., Rm. N3647, Washington, DC 20210; 202/219-8148, fax 202/219-5986
The agency develops and promulgates occupational safety and health standards, develops and issues regulations, conducts investigations and inspections to determine the status of compliance with safety and health standards and regulations, and issues citations and proposes penalties for noncompliance with safety and health standards and regulations. OSHA has set exposure limits, training guidelines, and protective-gear requirements for employees who work around the medical device sterilant ethylene oxide.

Occupational Safety and Health Review Commission
1120 20th St. N.W., 9th Fl., Washington, DC 20036-3419; 202/606-5398, fax 202/606-5050
An independent federal agency that decides contests of citations or penalties resulting from OSHA inspections of the workplace. The commission has established procedures for conducting hearings, receiving evidence, and rendering decisions by its administrative law judges.

Small Business Administration
Washington, DC; 800/U-ASK-SBA, fax 818/552-3260
Provides new and established small businesses with financial assistance, management counseling, and training. The administration also licenses and regulates small business investment companies. Special programs have been developed by SBA to expand and promote ownership of businesses by women and minorities.

U.S. Department of Commerce
International Trade Administration, Office of Microelectronics, Medical Equipment, and Instrumentation, Rm. 1015, Washington, DC 20230; 202/482-2470, fax 202/482-0975
One of the responsibilities of OMMI is to promote exports and increase international competitiveness of the U.S. medical device industry. The office is dedicated to market-development programs that promote medical products in international markets. These programs include working with industry to develop trade missions, events, and seminars that promote exports; participating and supporting trade negotiations to increase U.S. exports and international investments abroad; reducing and eliminating regulatory barriers that impede trade; preparing industry analysis reports that affect U.S. competitiveness and future trends; and providing counseling to medical device firms interested in entering or expanding sales in international markets. The Trade Information Center at the Commerce Department (800/USA-TRADE) is a comprehensive resource for information on all federal government export assistance programs.

U.S. Nuclear Regulatory Commission
Medical, Academic, and Commercial Use Safety Branch, Washington, DC 20555; 301/415-7231 or 301/415-8200, fax 301/415-5369
Regulates the civilian use of by-product materials in the United States to protect the public health and safety, the environment, and the common defense and security. The agency reviews and issues licenses for construction and operation of nuclear power plants and other nuclear facilities and it licenses the possession and use of nuclear materials for research and medical, industrial, and educational purposes.

EUROPEAN ORGANIZATIONS AND ASSOCIATIONS

Association of British Health-Care Industries (ABHI)
St. George's House, 195-203 Waterloo Rd., London, SEI 8WD, UK; (44) 171 7873060, fax (44) 171 787 3061
The UK trade association for the medical device and systems industries. Members include manufacturers, distributors, and associated service companies.

EUROM VI
Secretariat, P.O. Box 40 06 63, D-50858 Köln, Germany; (49) 221 94 86 28-32, fax (49) 221 48 34 28
The medical technology section of the European Federation of Precision, Mechanical, and Optical Industries.

EUROMCONTACT
B.P. 08, 50520 Juvigny Le Tertre, France; (33) 02 33 49 86 04, fax (33) 02 33 49 86 04
A European trade association representing contact lens manufacturers and importers.

European Association of the Surgical Suture Industry
Karlstr. 21, D-60329 Frankfurt am Main, Germany; (49) 69 25561338, fax (49) 69 25561471
Founded in 1972 to represent and promote the common interests of manufacturers of sterile surgical sutures. Its membership of 24 manufacturers represents 90% of the European Union trade in this market.

European Committee for Electrotechnical Standardization (CENELEC)
Rue de Stassart 35, B-1050 Brussels, Belgium; (32) 25 196871, fax (32) 25 196919
An electrotechnical standards­setting body with members of standards institutions of the European Union and nations of the European Free Trade Association. Standards are adopted by majority voting.

European Committee for Standardization (CEN)
Rue de Stassart 36, B-1050 Brussels, Belgium; (32) 2 550 0811, fax (32) 2 550 0819
Membership consists of standards institutions of the European Union and the nations of the European Free Trade Association. Standards are adopted by qualified majority voting.

European Confederation of Medical Devices Association (EUCOMED)
Rue du Collège St. Michel 17, Box 8, B-1150 Brussels, Belgium; (32) 2 7722212, fax (32) 2 7713909
Members include European manufacturers and distributors of medical devices and accessories, excluding active implantable medical devices, in vitro diagnostic devices, active capital equipment, and optical and emergency equipment.

European Diagnostic Manufacturers Association
Rue du Collège St. Michel 17-23, Box 7, B-1150 Brussels, Belgium; (32) 2 7722225, fax (32) 2 7722329
A nonprofit confederation of diagnostic manufacturers and diagnostic national associations representing the pan-European interests of its members.

IAPM (International Association of Medical Prosthesis Manufacturers)
Rue du Collège St. Michel 17, Box 6, B-1150 Brussels, Belgium; (32) 2 770 0564, fax (32) 2 770 3246
An association representing manufacturers of active and nonactive implantable medical devices.

International Electrotechnical Commission
Rue de Varembé 3, B.P. 131, CH-1211 Geneva 20, Switzerland; (41) 22 9190211, fax (41) 22 9190300
An organization creating international standards for the electrical and electronic industries, IEC has developed a series of standards specifically for electromedical equipment. Standards can enable electrical and electronic equipment to work together no matter where it is designed, manufactured, assembled, or used. IEC international standards are used in more than 100 countries.

International Organization for Standardization (ISO)
Rue de Varembé 1, CH-1211 Geneva 20, Switzerland; (41) 22 7490111, fax (41) 22 7333430
A worldwide federation of national standards bodies from some 120 countries that promotes the development of standardization and related activities to facilitate the international exchange of goods and services and to develop intellectual, scientific, technological, and economic cooperation. ISO's technical committees, working groups, and ad hoc study groups represent the viewpoints of manufacturers, vendors and users, engineering professions, testing laboratories, public services, governments, consumer groups, and research organizations in each member country.

Society of Plastics Engineers
SPE Scandinavia, Mikkel Bryggers Gade 10, DK-1460 Copenhagen, Denmark; (45) 33 114122, fax (45) 33 133859
A worldwide professional association of 37,000 members involved in the design, engineering, R&D, processing, and production of plastics. SPE Scandinavia sponsors the annual European conferences and exhibitions, Medical Plastics and Pharmaceutical & Medical Packaging.

Food and Drug Administration, Center for Devices and Radiological Health

Division of Small Manufacturers Assistance
1350 Piccard Dr., HFZ-220, Rockville, MD 20850; 800/638-2041 or 301/443-6597, fax 301/443-8818; electronic docket: 800/252-1366 or 301/594-2741; facts-on-demand fax: 800/899-0381 or 301/827-0111
FDA, the primary government regulator of medical technology, holds authority over members of the medical device industry regarding safety and efficacy. All medical device manufacturers and some types of distributors must register with FDA annually and submit a list of the devices they distribute commercially. Manufacturers must also comply with FDA regulations, including those regarding marketing clearance, manufacturing, quality control, labeling, distribution, and postmarket surveillance. The Division of Small Manufacturers Assistance (DSMA) helps manufacturers understand FDA regulations. DSMA specialists answer questions over the phone, in person, or through the mail. Manufacturers can attend DSMA workshops and conferences. DSMA also has copies of FDA policy statements, guidelines, and regulations. Manufacturers are encouraged initially to request assistance from an FDA district office or an FDA small business representative office. There are 21 FDA district offices throughout the United States and Puerto Rico, as well as small business representative offices in New York, Philadelphia, Atlanta, Chicago, Dallas, Denver, and San Francisco.

Key phone numbers within the Center for Devices and Radiological Health:

Office of Compliance 301/594-4692
Office of Device Evaluation 301/594-2022
Division of Cardiovascular, Respiratory, and Neurological Devices 301/443-8320
Division of Clinical Laboratory Devices 301/594-3084
Division of General and Restorative Devices 301/594-1184
Division of Ophthalmic Devices 301/594-2205
Division of Reproductive, Abdominal, Ear, Nose, Throat, and Radiological Devices 301/594-5072
Office of Health and Industry Programs 301/443-2845
Office of Surveillance and Biometrics 301/594-2812