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FDA offers guidance for remote medication systems

Device Regulation Alert: Safety, Compliance and Reimbursement News, October 29, 2007

The FDA's new special controls guidance provides manufacturers with information on the pre-market notification process for remote medication management systems.

The October 19 guidance was issued in connection with the classification of remote medication management systems as Class II devices and is identified in 21 CFR 880.6315.

Remote medication management systems store medications and allow providers to remotely schedule the patient's medication, issue notices to the patient about when to take the medicines, and release the medication into a delivery unit for the patient to access. The devices are intended to help providers manage "therapeutic regimens for patients in the home or clinic." Manufacturers of such devices will need to demonstrate the device satisfies the recommendations in the guidance or give equivalent assurances of the device's safety.

The FDA identifies the risks associated with the device and describes measures manufacturers should undertake to address those risks, in addition to the general controls. Those risks include:

• Improper dosing
• Cross-contamination
• Information security
• Device failure
• Electromagnetic interference
• Electrical and mechanical hazards

The FDA recommends addressing these risks by using simulation tests, labeling, software validation, and performance testing.

The guidance offers advice on addressing software validation, simulated use testing, electromagnetic compatibility, safety performance, and labeling in pre-market submissions.

Click here to review the guidance. Click here to read the final rule classifying the remote medication management system as a Class II. The final rule is effective November 17, 2007, and manufacturers should be following the guidance after that date.

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