viernes, 18 de diciembre de 2015

Consumer Information for Medical Devices Update: FDA proposes to restrict the sale, distribution, and use Sunlamp Products and amend the Performance Standard for Sunlamp Products

Today, the U.S. Food and Drug Administration issued two proposed rules regarding sunlamp products and updated the content on theTanning website and issued a press release and a Consumer Update article.
The FDA will issue a proposed rule to establish device restrictions for sunlamp products and UV lamps, which would restrict their use to individuals age 18 years and older and require adult users to sign a risk acknowledgement certification before use that states that they have been informed of the risks to health that may result from use of sunlamp products.
The proposed amendment to the performance standard for sunlamp products and UV lamps seeks to reduce risks to consumers by updating technical requirements to reflect current science and to more closely harmonize with the international Electrotechnical Commission (IEC) standard.  The FDA is proposing to change the requirements for the content, format, and location of certain required warning statements to make them more effective at communicating the risks associated with sunlamp products to consumers, among other safety changes and requirements.
The rules will be available for public comment for 90 days.

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