The US Food and Drug Administration (FDA) has unveiled a list of reusable medical devices for which it will require validation data regarding cleaning, disinfection and sterilization as well as validated instructions for use in premarket notification submissions.
The list has been published in accordance with the requirements established by the 21st Century Cures Act, and the additional information will need to be provided to the FDA as of August 8, 2017.
The FDA says its new requirements will ensure that the premarket requirements for the listed device types are clear and predictable, which will facilitate a more efficient review of 510(k)s. Contact us
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