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U.S. Department of Health and Human Services

Science & Research

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Volume IV - 13.13 Medical Device Standards

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Orientation and Training

Food and Drug Administration


Section 13 - Engineering

EFFECTIVE DATE: 10-01-03REVISED: 02-14-13

A. Objective

To introduce the trainee to sources of medical device standards and their use in the analyses of medical devices.

B. Assignment

The trainer will present information on medical device standards including policies, laws, and regulations prescribing the use of medical device standards by the Agency, sources of medical device standards, types of medical device standards (e.g., test methods, specifications, guides, and practices, etc.), and these standards in analyses of medical devices.

The trainee will be expected to become familiar with medical device standards and their use in medical device analyses through practical exercises assigned by the trainer.