Academy attempts to assure correct display of FDA clearance status

Academy attempts to assure correct display of FDA clearance status

By Richard N. Peterson

General Counsel

One of the unique features of the Academy’s Annual Meeting is the importance attached to notifying registrants of the U.S. Food and Drug Administration (FDA) clearance status of each device and pharmaceutical product exhibited. In an informal survey of other national medical societies, the Academy was alone in its coordination and cooperation with FDA staff in assessing the FDA status of products displayed in Annual Meeting technical exhibits.

The Academy’s Annual Meeting exhibitor rules specifically discuss notifying registrants of the FDA clearance status of all devices and pharmaceutical products displayed. They provide:

All products that are not FDA-approved for a particular use in humans or that are not commercially available in the United States will be permitted to be exhibited only when accompanied by the appropriate signs to indicate the device’s FDA clearance status.

The following are signs that should be displayed:

  • This device/drug is not cleared by the FDA for distribution in the United States.
  • This device/drug is intended to be used in the United States as described in the product’s labeling.

Signs must be easily visible and placed near the devices or drugs and on any graphics depicting the device or drug. Exhibitors are cautioned about the FDA’s prohibition of promoting devices or drugs that are cleared for marketing for unapproved uses.

For the last 16 years, the AAOS Committee on Exhibits and the staff of the FDA’s Center for Devices and Radiological Health have worked to screen exhibits for possible omissions and inappropriate or misleading labeling before the Technical Exhibits open to registrants. This is an attempt to assure that accurate information is provided by all exhibitors regarding the regulatory status and approved labeling of the devices or pharmaceutical products for the benefit of the registrants at the Annual Meeting.

During this pre-meeting “walk-through,” each exhibitor must have a staff contact in the booth. In addition, after the initial walk-through, members of the Committee on Exhibits and FDA staff may continue spot checks to help insure that the correct marketing and use information is being accurately shared with registrants. This compliance program will continue during the 2007 Annual Meeting.

The FDA clearance status of a device or pharmaceutical product(s) is important information for orthopaedic surgeons. Although orthopaedic surgeons are not required to discuss FDA clearance status with individual patients, this information may be used as one indication of the relative safety and efficacy of the device or pharmaceutical product. It is also acceptable for orthopaedic surgeons to use devices or pharmaceutical products for a purpose not on the product’s labeling if they, in their best medical judgment, determine it is in the best interest of the patient, based on current medical and scientific knowledge.

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