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Features articles of interest on language translation and localization, culture, language technology and other related topics. The goal of the Global Advisor Newsletter is to inform and entertain.

Other Editions

Sixth Edition

The U.S. Medical Device Regulatory System - Classification of Medical Devices

Glossary of Related Terms

Translation Memory Tools

Classification of Medical Devices

The U.S. Congress classifies medical devices in three regulatory classes, according to the level of control deemed necessary to ensure that they are safe and effective. To make the appropriate recommendation to the Commissioner regarding the classification of regulatory control appropriate to a medical device, a classification panel reviews the device taking into consideration, among other pertinent factors:

1. The persons for whom the use of the device is represented or intended.
2. The conditions of use for the device, including conditions of use prescribed, recommended, or suggested in the labeling or advertising of the device, and other intended conditions of use.
3. The probable benefit to health from the use of the device, weighed against any probable injury or illness from the use of the device.
4. The reliability of the device.

Manufacturers can refer to Title 21 - Food and Drugs, Parts 862 through 892 of the Code of Federal Regulations (CFR) - to determine in which of these classes their new product is likely to fall. For information on devices already in the market, refer to Classification Names for Medical Devices and Classification Names for In Vitro Diagnostic Products, distributed by FDA's Center for Devices and Radiological Health (CDRH). For more information, visit the FDA web site.

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Glossary of Terms

Medical Device

This term defines a wide spectrum of products, ranging from tongue depressors to highly sophisticated implantable devices. According to Section 201 of the Federal Food, Drug, and Cosmetic Act (FD&CA), a medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article including any component, part or accessory which is:

 

	recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them;
	intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease in man or other animals; or
	intended to affect the structure of any function of the body of man or other animals; and which does not achieve its primary intended purposes through chemical action within or on the body of man...and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Class I Medical Devices

Examples of these are manual stethoscopes, surgical scapels and forceps. These devices present the least safety risk to the operator or the patient. Thus, they are subject only to the general controls authorized by Section 501 (adulteration), 502 (misbranding), 510 (registration), 516 (banned devices), 518 (notification or other remedies), 519 (record and reports), and 520 (general provisions) of the FDA.

Class II Medical Devices

Examples of these are endoscopes which provide access, illumination, and observation or manipulation of body cavities, hollow organs, and canals; and surgical lasers for many indications. In addition to the requirements of Class I, these devices are subject to performance standards promulgated under Section 514 (performance standards) of the FD&CA. These are devices for which general controls alone are considered sufficient to establish their safety and effectiveness. Special controls include performance standards, postmarket surveillance, patient registries, guidelines and recommendations.

Class III Medical Devices

These are devices for which premarket approval is or will be required. They include devices that are life-supporting or life-sustaining, or for a use which is of subtantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of injury. Examples are indwelling gas analyzers, implantable cardiac pacemakers, cardiac arrhythmia alarms, and automatic heparin analyzers. A device is considered Class III if there is not enough information to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness.

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In Vitro Diagnostics

In Vitro Diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequalae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201 (h) of the Federal Food, Drug, and Cosmetic Act ... and may also be biological products subject to section 351 of the Public Health Service Act.

Examples of in vitro diagnostic medical devices are kits to test for pregnancy, AIDS, and glucose levels.

Reference Sources: Code of Federal Regulations, U.S. Government Printing Office; Medical Device Industry Fact Book, 3rd Edition, produced by Cannon Communications, Inc.; International Labeling Requirements for Medical Devices, Medical Equipment, and Diagnostic Products.

Translation Tools

There are a variety of computer aided translation tools in the market. When used effectively, with the proper training and support, they can improve translator productivity and reduce translation cycle time. One such tool is translation memory. It helps translators to manage and re-use previously translated text and is excellent for use on documentation projects that exhibit a certain amount of repetitiveness and updating.

Briefly, translators can use translation memory tools to keep track of text they have translated and re-use it, by exact or "fuzzy matching", to translate new text. Exact match means just what it says - the system compares the new source text to the source text that was previously translated and identifies those units text that are identical to both. Then, it presents the translator with the translated units. Extending the reuse of previously translated text even further, the fuzzy match feature identifies those units in both source texts that are reasonably close and provides them to the translator, highlighting the differences to facilitate the process of making whatever adjustments are necessary to achieve an exact match.

Translation memory is also an excellent tool in document translation environments where ambitious release dates require translators to begin the translation, even when the writers of the source text have not reached the final phase. By facilitating the management of changes, translation memory helps to avoid potentially chaotic situations that result when authors text make frequent alterations to the source text while the translation is in process.

Some of these tools also permit translators to work in their favorite work processor or text editing tool, without having to worry about desktop publishing of software code. It does this by splitting the code from the text and saving each one in a separate file. When the translation portion of the project has been completed, the person responsible for the formatting the document can rebuild it by joining the translated text with the original code and outputting a file in the desired finished format.

Used in conjunction with a terminology management tool, a translation memory tool can be a powerful translation aid. The terminology management tool is used to compile a dictionary of terminology specific to a company, product, project, subject, etc. that can be used interactively with the translation memory tool as a look up dictionary.

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