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Regulatory & Compliance / Glossary

510(K)

A premarket notification [510(k)] is a marketing application submitted to FDA to demonstrate that the medical device a company wishes to market is as safe and as effective or substantially equivalent to a legally marketed device that was or is currently on the U.S. market and that does not require premarket approval. The premarket notification requirements are found in 21 CFR Part 807, Subpart E.

Most devices are cleared for commercial distribution in the U.S. by the premarket notification [510(k)] process. Most class I devices are exempt from the 510(k) requirement by regulation. However, they are not exempt from other general controls, such as establishment registration and device listing. Before marketing a medical device which is not exempt from the marketing clearance process, the manufacturer must submit a premarket notification [510(k)] or a premarket approval (PMA) application to FDA. The manufacturer cannot market the device unless the firm receives a marketing clearance letter from FDA as stated in section 513(I)(1)(A) or section 515(d)(1)(A)(I) of the FD&C Act.

BSI

British Standards Institution. SonoSite's "notified body" under the European Union Medical Device Directive (MDD) - Council Directive 93/42/EEC of 14 June 1993 concerning medical products. The primary role of a Notified Body is to provide services for conformity assessment on the conditions set out in the New Approach Directives in support of CE marking. This normally means assessing the manufacturers conformity to the essential requirements listed in each directive.

CMDCAS

Canadian Medical Device Conformity Assessment Scheme. Manufacturers selling class II, III and IV devices in Canada must be registered by a quality systems registrar accredited under the Canadian Medical Devices Conformity Assessment System(CMDCAS).

CSA

Canadian Standards Association. CSA International-a leading provider of product testing and certification services.

CSA tests products for compliance to national and international standards, and issue certification marks for qualified products. Certification marks tell potential customers and users that a product has been evaluated by a formal process-involving examination, testing and follow-up inspection-and that it complies with applicable standards for safety and performance. In the United States, CSA is a nationally recognized testing laboratory (NRTL) under OSHA.

EC

European Community

EMC

Electro magnetic compatability

EMI

Electro magnetic interference

EU

European Union. The twenty-five member states as of May 1, 2004:

Austria, Belgium, Cyprus*, Czech Republic*, Denmark, Estonia*, Finland, France, Germany, Greece, Hungary*, Ireland, Italy, Latvia*, Lithuania*, Luxembourg, Malta*, Netherlands, Poland*, Portugal, Slovakia*, Slovenia*, Spain, Sweden, United Kingdom * New member as of May 1, 2004

FDA

United States Food and Drug Administration

ISO

International Organization for Standardization. The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from some 100 countries, one from each country.

ISO is a non-governmental organization established in 1947. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity. ISO's work results in international agreements which are published as International Standards.

ISO is not an acronym for International Organization for Standardization, but a Greek word meaning equal. (Eg. Isosceles triangles, meaning equal sided), and is valid in English, French and Russian, the three official languages of ISO.

MDD

Medical Device Directive (MDD). EU Council Directive 93/42/EEC of 14 June 1993 concerning medical products.