Recommendations re: FDA Regulations

• Restore Devices to Manufacturer Specifications: Reutilization programs that refurbish devices should ensure that the device functions the way the manufacturer intended. The overriding concern is the safety of the device. Refurbishers may not modify devices to different safety or performance specifications. If the device was not meant to be used for a purpose as originally designed and marketed by the manufacturer, it may not be modified for that purpose by a refurbisher.

• Appropriately Inform Consumers: Reutilization programs should consider whether the safe operation of the device involves providing the manufacturer’s specifications, instructions, or owner’s manual to the consumer. Additional training on the device may also help the consumer to safely operate the device and obtain the greatest benefit from the device. Refurbishers may not market a device as a new device. Consumers should be aware that the device they are being given or sold was previously used.

• Use Qualified Technicians: If the manufacturer’s specifications indicate that a repair or an adjustment must be done by a qualified technician, unless the specifications indicate the technician must have a specific certification, a qualified technician is taken to mean someone with experience refurbishing that type of device. Unless specified otherwise, a qualified technician is a person who can be trusted to safely service or repair the device.