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FDA seeks comment on medical device injury rule

Ambulatory Surgery Reimbursement Update, March 1, 2005

The U.S. Food and Drug Administration (FDA) wants to amend the regulations governing the reporting of deaths, serious injuries, and certain malfunctions related to medical devices, and it wants your help.

The FDA plans to make technical corrections and simplify the language of the regulation to make it easier to understand.

The proposed rule would not change the substantive regulatory requirements described in the document. The rule attempts to "incorporate plain language in this rule as much as possible."

In addition, the FDA says it has "tried to make each section of the companion proposed rule easy to understand by using clear and simple language rather than jargon, by keeping sentences short, and by using active voice rather than passive voice whenever possible."

To view the rule, click here, or here (Adobe Acrobat required).

Instructions on how to submit comments can be found here or here. Comments can also be e-mailed to fdadockets@oc.fda.gov.

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