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Section 708 in the Food and Drug Administration Safety and Innovation Act (FDASIA), enacted in 2012, added FDA authority to section 801(a) of the FD&C Act to destroy any refused drug valued at $2500 or less (or such higher amount as the Secretary of the Treasury may set by regulation). To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

The final rule will amend the administrative destruction provisions in 21 CFR 1.94 to include devices in order to implement FDA’s new authority under section 2 of the Safeguarding Therapeutics Act (Pub. L. 116-304) to administratively destroy any refused device valued at $2500 or less (or such higher amount as the Secretary of the Treasury may set by regulation). These refused devices include illegal medical devices that are being imported to diagnose or treat COVID-19 such as test kits, respirators, and face masks. Other illegal devices that pose significant public health concern include illegal contact lenses.