CDRH PROMO UNTITLED LETTERS.

The following untitled letters were issued by the Promotion and Advertising Staff of the Center for Devices, Office of Compliance (CDRH-OC) in 2001. Copies of these letters are available to subscribers from RECORD-RETRIEVE for $7 plus retrieval.

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Bio-Vascular, Inc., Saint Paul, MN, June 4, 2001 (CDRH-OC). Concerning the print and Web site promotions of the firm's Class II Dura-Guard dural repair patch, the agency had problems with the firm's claim: "Animal studies have corroborated that adhesions are minimal and are compatible to that found with native dura implants." FDA stated "it is still unclear whether animal studies using Dura-Guard can be extrapolated to clinical studies in humans" and that immunological risks, such as the transmission of Creutzfeldt-Jacov Disease, needed to be considered. Web

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Codman & Shurtleff, Inc., Raynham, MA, June 4, 2001 (CDRH-OC). FDA stated that the firm's promotional material contained "several phrases" implying the firm's Ethisorb Dura Patch "plays a role in minimizing or reducing adhesions," a claim that had not been cleared by the agency. The Dura Patch is a 510(k)-cleared synthetic implant for bridging defects in the dura mater.

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Diagnology, Inc., Research Triangle Park, NC, June 21, 2001 (CDRH-OC). FDA stated that the firm's print and Web site promotions for its POCkit HSV2 Rapid Test genital herpes IVD "strongly suggest" that the IVD is an appropriate screening tool in the general population when "neither characterization reflects the cleared use" of the device. The 510(k)-cleared device is indicated as a "single unit, membrane-based immunoassay for the qualitative determination...of circulating IgG antibodies specific for herpes simplex virus type 2," according to FDA. Web

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Genzyme Biosurgery, Cambridge, MA, June 4, 2001 (CDRH-OC). The letter took issue with several statements on Genzyme's Web site claiming the firm's Sepramesh biosurgical composite could reduce adhesions "from one organ to another." FDA noted that the product was cleared via 510(k) for "use in the reconstruction of soft tissue deficiencies, such as the repair of hernias" and that the firm had "blurred the distinction between the cleared intended use of Sepramesh and the [PMA] approved indications for use of Seprafilm." Web

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Integra NeuroSciences, Plainsboro, NJ, June 4, 2001 (CDRH-OC). The agency stated that the firm needed to ensure that promotional claims for the firm's bovine-derived DuraGen dural graft matrix were consistent with its Class II labeling. The letter noted that Integra's print and Web site promotions for the device "contain claims that DuraGen has minimum potential for adhesions and encapsulation" adding that without "further clarification, the reader may incorrectly infer DuraGen plays a role in reducing adhesions from one organ to another, rather than between the device and an adjacent organ." Web

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Rowen Laser Vision and Cosmetic Center, Towson, MD, June 21, 2001 (CDRH-OC). The letter noted the firm's print and television ads entitled "Over 40? Wearing Reading Glasses or Bifocals, and Fed Up?" marketing the Sunrise Hyperion LTK laser cannot imply that the patient will not need reading glasses or bifocals after the procedure, noting the laser is indicated for the temporary reduction of hyperopia.

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Tillotson Healthcare Corporation, Bedford, NH, June 14, 2001 (CDRH-OC). FDA stated that promotions for the firm's Ultra Preserve latex gloves with Aloe Vera failed to include labeling cautioning possible allergic reaction. Also, the agency noted the firm's claim that the gloves contain "less than 10ug/g of antigenic protein" not acceptable as the present guidance "does not allow a protein labeling statement or claim below the current 50 ug/g of glove sensitivity limit." Lab, Web