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  • 1.  section 6(a) of the Toxic Substances Control Act

    Posted 18-Feb-2021 13:51
    What do Medical Device Manufacturer  (IVD) need to address regarding section 6(a) of the Toxic Substances Control Act similar to REACH in EU. 


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    Christian Okofu
    Design Assurance Engineer
    Anaheim CA
    United States
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  • 2.  RE: section 6(a) of the Toxic Substances Control Act

    Posted 18-Feb-2021 16:40
    Hi Christian.

    Remember an important issue here is the fact that the US Environmental Protection Agency regulates chemicals while the US Food & Drug Administration regulates devices.  As such, EPA has routinely taken the position that they are in charge of chemicals when sold as chemicals and when sold as chemicals not used in industries regulated by other US agencies.  This is a hugely different position than in the EU with REACH.  REACH applies to any chemical in any product from any supply chain when either manufactured in or imported into the EU.  So effectively, TSCA has not typically been used to regulate any FDA regulated product unless the product releases the chemical in some way or the chemical is sold as say a reagent to be used in these devices and could be sold to other industries and subsequently released.  With that said, there are potentially other regulatory schemes that might catch these chemicals in individual states (I am sure you would agree that Prop 65 could be used to regulate a device chemical if there were evidence of an "exposure" according to the definitions) so just because federal law might allow you a "pass" on the regulation of your chemical(s) involved the company still needs to analyze whether or not there are other issues out there that might impact your product and any necessary warnings on package.

    Feel free to contact me if there are specific questions or issues that you might have.  I am not a consultant but I have been in the field long enough to have a fair understanding of the issues involved.

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    Victor Mencarelli
    Global Director Regulatory Affairs
    MelvilleNY
    United States
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    Original Message


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