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Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff

In a recent FDA announcement, the Agency updated their guidance for the ODE staff on how to determine the intended use of a device for 510(k) review.

Section 513(i)(1)(E) of the Act generally limits the determination of the intended use of a device that is the subject of a premarket notification (510(k)) to the proposed labeling contained in the submission.

"Labeling" is defined in Section 201(m) of the Act as "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article." Proposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for use are required to be submitted in a 510(k) for review during the substantial equivalence determination. (See 21 CFR 807.87(e))

In addition to the restrictions regarding the determination of intended use, the law defines the procedures to be followed if the Office Director believes “that there is a reasonable likelihood that the device will be used for an intended use not identified in the proposed labeling for the device" and "that such use could cause harm.” (See Section 513(i)(1)(E)(ii)).

At time an FDA reviewer may encounter during the 510(k) submission that there are instances in which the design of the device or published literature referencing the subject device or a similar device, would lead one to believe that there may be an intended use different than that appearing in the labeling. If this situation occurs, the reviewer should bring the discrepancy to the attention of senior division management.

The reviewer and division management should consider:

• Whether there is a reasonable likelihood that the device will be used for an intended use not identified in the proposed labeling for the device, and
• if such use could cause harm to the patient or the consumer.

It this were to occur this is to be reviewed with the firm and if it could not be rectified then with the Division Chief.

For more information on the FDA guideline for Off Label use of a 510(k) device visit the FDA website at: http://www.fda.gov/cdrh/ode/guidance/857.html or contact mdi directly at offlabel@mdiconsultants.com or call 516-482-9001.

U.S. AGENT SECTION

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