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Info on Device Sterilization Sent to OMB

04/26/2010

Federal Register Notice: FDA’s proposed collection of information, “Agreement for Shipment of Devices for Sterilization — 21 CFR 801.150(e),” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. FDA regulations in 21 CFR 801.150(e) establish a control mechanism by which firms may manufacture and label medical devices as sterile at one establishment and ship the devices in interstate commerce for sterilization at another establishment. Under Sec. 801.150(e)(1), manufacturers and sterilizers may sign an agreement containing the following: (1) Instructions for maintaining accountability of the number of units in each shipment; (2) acknowledgment that the devices that are nonsterile are being shipped for further processing; and (3) specifications for sterilization processing. This allows the manufacturer to ship misbranded products to be sterilized without initiating regulatory action and provides FDA with a means to protect consumers from use of nonsterile products. To view this notice, click here.

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