FDA Proposes to Extend Administrative Destruction Procedures to Medical Devices
FDA is proposing to amend its regulations on administrative detention to provide for the destruction of low value medical devices that have been refused admission to the U.S., and modify its procedures so the agency can more easily destroy low value shipments of drugs, it said in a notice released Oct. 6. Comments on the proposal are due Dec. 6.
Under the proposed rule, FDA would extend to medical devices its current authority to destroy low value drugs that have been refused entry without providing an opportunity to the owner or consignee to export the drug or device. The new procedures would apply to medical devices valued at $2,500 or less, with the Treasury Department able to raise the threshold. As with drugs, the owner or consignee of the device would be given notice and the opportunity to present testimony that the shipment is admissible.
That would be a change from current procedures, where the owner or consignee can request to recondition the device, and the onus is on the owner or consignee to destroy the device. Currently, devices shipped via international mail also must be returned to the sender.
The proposed rule would also modify procedures for administrative destruction of low value drug shipments so that FDA would be able to destroy refused drug shipments based on the appearance that the drug is adulterated, misbranded, counterfeit or unapproved, if the owner or consignee does not request to present testimony of admissibility. Previously, the agency could only resort to administrative destruction if it found the device was actually adulterated, misbranded, counterfeit or unapproved.
The new authority for administrative destruction of low value devices was given to FDA by the Safeguarding Therapeutics Act, signed in to law in January 2021.
FDA said the new procedures will help address the importation of illegal devices by way of international mail and express couriers, including fraudulent devices that purport to diagnose, prevent or treat COVID-19, such as test kits, respirators and face masks, as well as other devices that “pose significant public health concerns if counterfeit, unapproved, or unauthorized, or otherwise misbranded or adulterated,” such as contact lenses and blood glucose test strips.
FDA said the new procedures will be implemented only at international mail facilities and express couriers, and not for other commercial air, land and ocean shipments. Internal FDA data shows the “majority of devices offered for import, valued at $2,500 or less, and refused in [fiscal year] 2022 were shipped via international mail and express couriers," the agency said.
If finalized, the proposal could result in cost savings for express couriers and the U.S. Postal Service “from returning fewer refused devices to their country of origin,” FDA said.