Summary: Attachment 1
NEW MEDICAL DEVICE AND TECHNOLOGY REQUEST FORM
A medical device is defined by the FDA as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or
other similar or related article, including any component, part, or accessory, which is intended for use in the diagnosis of disease or
other conditions, or in the cure, mitigation, treatment, or prevention of disease; or is intended to affect the structure or any function of
the body; and does not achieve its primary intended purposes through chemical action within or on the body; and is not dependent
upon being metabolized for the achievement of its primary intended purpose(s). Note: Computer software may fall under this
definition of device.
Please mark the technology/equipment/device request type:
Evaluation: Start date: _________________
End date: __________________
Technology/equipment/device for patient research
(Complete sections A, B, C and D only)
Intended purchase/loan of new technology/equipment/device Intended to reprocess a supply labeled for single use
Product to be added / deleted from the Medical Center
Storeroom (chose one) : Added Deleted
Complete the applicable sections of the form, obtain approval (electronic or hard copy) and route with accompanying literature to:
· Barbara Strain, Supply Chain Management; (firstname.lastname@example.org); fax 244-7587; or Box 800690.
· Your request will be routed for internal processing.
· You will be notified by e-mail once the request has been registered.