CDRH ADVERTISING UNTITLED LETTERS

The following are summaries of >untitled letters' issued by the Center for Devices' Office of Com-pliance (OC) for promotion violations during the first four months of calendar year 1998. Each letter is available to subscribers from RECORD-RETRIEVE for $5 plus retrieval. Company re-sponses also are available, but there are neither 483s nor EIRs.

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Alcon Labs, Ft. Worth, TX, Feb. 3 (CDRH-OC). After Alcon submitted data in response to an untitled letter dated Aug. 7, 1997, (Doc. 6455W) regarding claims for Opti-Free SupraClens Daily Protein Remover, FDA said the studies did not address significant variables and did not support the claim that "lenses will be deposit-free when SupraClens is used as directed." The agency also found an example of a Bausch & Lomb ad for ReNu Multi-Plus Multi-Purpose Solution, submitted by Alcon, "qualitatively different" from the Alcon ad because it contained more moderate language. In addition, FDA noted that a month after the company agreed to stop using the phrase, "Keeps lenses like new longer," the wording appeared in a TV ad in January 1997. The agency asked for confirmation that Alcon had discontinued us-ing this language. The firm also was asked to submit a corrective action plan.

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Allied Biomedical, Paso Robles, CA, March 26 (CDRH-OC). After learning that the company promoted Kelocote Gel at the meeting of the American Academy of Dermatology, Orlando, FL, Feb. 27-March 4, 1998, FDA asked for cop-ies of all product labeling and promotional materials for this product.

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Allied Biomedical, Paso Robles, CA, May 4 (CDRH-OC). FDA said labeling and promotional materials for Kelocote Gel and Laser Gel exceeded the intended use of reducing keloid size and erythema. The agency objected to claims for accelerating healing and preventing the return of excised scars, as cited in a "Dear Doctor" letter, and a claim for "aiding the healing process," as noted on the firm's Web site. Allied was asked for a corrective action plan.

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Arrow International, Reading, PA, Feb. 3 (CDRH-OC). Noting that the Model 3000 Constant Flow Implantable In-fusion Pump with Bolus Safety Valve was "indicated for the continuous regional intra-arterial delivery of 2'-deoxy-5-fluorouridine...heparinized saline, normal saline, and bacteriostatic water," FDA asked for data to support a claim in a letter that the device "is the safest and smallest infusion pump available today."

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Biolase Technology, San Clemente, CA, March 17 (CDRH-OC). After a dentist received an invitation to hands-on training seminars in the use of the Millenium Er Cr YSGG Laser for cutting dental tissue, FDA said this use was still under review. The agency referenced quotes from a press release and the Internet regarding trade shows and pending FDA clearance, as well as a teleconference in which a Biolase official asserted that the Millenium was cleared under the 510(k) for the Biolase Elmer Laser System. The letter requested information on the training sessions and the Elmer device.

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Biomatrix, Ridgefield, NJ, March 23 (CDRH-OC). FDA said that, although the application for Synvisc included data supporting effective treatment for up to 18 months, the approved labeling limited treatment to 12 weeks. The agency said continued promotion for more than 12 weeks would result in misbranding and adulteration. In addition, the agency cited a brochure with incomplete prescribing information.

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Canyon Drive Clinic Wellness Center, Amarillo, TX, Jan. 6 (CDRH-OC). A newspaper ad for the Silhouette Laser, cleared as a therapeutic massager for relieving minor aches and pains, was cited for a cellulite elimination claim. FDA said such claims may result in misbranding or adulteration.

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Cardiomedics, Irvine, CA, Feb. 20 (CDRH-OC). Promotional materials for the CardiAssist Counterpulsation device, allegedly distributed at an American Heart Assn. meeting in the fall of 1997, were deemed misleading because they misrepresented features of a counterpulsation device manufactured by Vasomedical.

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Chattanooga Group, Hixson, TN, Jan. 6 (CDRH-OC). FDA said an ad in "Chiropractic Products" presented claims for the Carpal Trac that exceeded the 510(k). The product was cleared "as a traction accessory device intended for medical purposes to be used with powered traction equipment to aid in exerting therapeutic pulling forces on the pa-tient's body," while the ad promoted the device for treating carpal tunnel syndrome, according to the agency.

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Davol, Cranston, RI, Jan. 14, Feb. 5, March 5 (CDRH-OC). In a series of letters, CDRH on Jan. 14 requested copies of all labeling and promotional materials currently in use regarding the Bard Composite Prosthesis. The company is a subsidiary

of C.R. Bard. On Feb. 5, FDA determined that booklets and flyers submitted by Davol on Jan. 22, and which promoted the device, exceeded the firm's 510(k). The agency said the device was cleared for use in reconstructing soft tissue deficiencies, but was being marketed for minimizing the risk of adhesions, a new intended use that required a new 510(k). Davol also was asked to support a claim that the device was "designed to produce a >tension-free' repair." The agency requested a corrective action plan. After reviewing additional materials, CDRH on March 5 decided that Davol could make the adhesion minimiza-tion claim if it revised the language to make it clear that the company meant adhesions to the prosthesis, not to other organs, and included indications for use, as well as all relevant hazards. The agency noted that Davol had promised documentation to support its "tension-free" repair claim.

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Douglas Community Medical Center, Roseburg, OR, March 2 (CDRH-OC). FDA cited "inappropriate claims" for the Advanced Breast Biopsy Instrumentation System (ABBI), manufactured by U.S. Surgical, in a newspaper ad. Stating that the device was cleared for diagnostic breast tissue sampling, the agency objected to statements referring to excision of a growth. Noting that core needle biopsies are usually performed under local anesthesia, the agency ob-jected to an implication that the ABBI was unique in this respect. FDA requested that Douglas stop using this and other similar ads. The agency asked the center where it got the information used as a basis for this claim, referencing allegations that it came from materials provided by U.S. Surgical.

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Jazmon Technologies, Massillon, OH, Jan. 6, March 13 (CDRH-OC). On Jan. 6, FDA requested a copy of all labeling and promotional material in use for the CTR 2000 Wrist Exercise Device. Responding on March 13 to the company's law firm, Dilling and Dilling of Chicago, FDA said that while the CTR 2000 Wrist Exercise Device was exempt from 510(k) requirements as non-measuring exercise equipment, claims for relieving carpal tunnel syndrome removed the exemption. A disclaimer in the instructions for use, stating that the device was not intended as a cure for any medical condition, did not negate claims in promotional materials or labeling, the agency stated.

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Neuromedical Systems, Suffern, NY, Jan. 30 (CDRH-OC). FDA raised concerns about a campaign for the Papnet system. The agency said a consumer-directed ad appeared "to attempt to create among consumers the same fear that we addressed" in an October 1996 letter (Doc. 5299W, May 19, 1997, issue, page 8) and suggested that the device could detect cervical abnor-malities, a claim that changed the intended use. Further areas of concern included distributing excerpts of an article out of context, thus misrepresenting the author's conclusions; a slide show containing unsupported statements implying shortcom-ings with monolayer slide preparation; a document distributed to practitioners alleging problems with Cytec's ThinPrep Pap Test; an unsupported claim that only the U.S. allows liquid-based slide preparation in place of conventionally prepared Pap smears; and an "inappropriate claim" that ThinPrep will lead to malpractice liability. FDA also alleged that press releases promoted Papnet for detecting esophageal cancer, an unapproved use. The agency asked for copies of all promotional materi-als for Papnet distributed since June 1, 1997, along with any that referred to ThinPrep.

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Orthofix, Richardson, TX, Feb. 3 (CDRH-OC). FDA considered efficacy-based comparisons between the Physio-Stim bone growth stimulator and other such devices misleading because the devices were not evaluated under the same condi-tions. The agency said this was the conclusion reached at a May 1997 FDA/BoneGrowth Stimulator Industry meeting. Orthofix was asked to submit a corrective action plan.

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Phoenix Management, Fountain, CO, Feb. 3 (CDRH-OC). FDA said a videotape broadcast on the QVC Home Shopping Network promoted the Hearing Aid Telephone Interconnect System (HATIS), a hearing aid accessory, for the uncleared in-tended use of reducing or eliminating background noise. The company also was faulted for promoting HATIS for use with cochlear implants, contrary to a 1994 agreement with the agency. In addition, FDA cited other unsupported claims in uniden-tified promotional materials. Phoenix was asked to revise the ads, including its Web site, to make it clear that effectiveness varies with different patients and hearing aids.

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Phoenix Biomedical, Valley Forge, PA, April 29 (CDRH-OC). The company was faulted for preclearance ads for the Diamond valve because they included claims that were not covered by marketing clearance for any predicate device. FDA said CDRH's Office of Device Evaluation had requested data to support these claims and suggested they be re-moved from the ads.

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PIP/USA, Miami, FL, March 2 (CDRH-OC). A "Dear Doctor" letter was cited for "numerous inappropriate statements" regarding saline implants. Among these was an assertion that the company "passed...the FDA's GMP inspection with the highest rating," which FDA termed "not an appropriate thing to say" in the context of the company's history of warning letters for GMP violations, as well as incorrect in implying that GMP compliance was a basis for FDA endorsement. The agency also criticized a reference to "FDA's ISO 9000 inspection," which is nonexistent; a reference to 510(k) clearance; and unsupported claims for "optimal aesthetic results" and a lower deflation rate. The letter asked whether PIP was currently dis-tributing this or any similar materials.

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The S.F. Group, Grand Junction, CO, April 17 (CDRH-OC). FDA objected to an ad for Durasil Silicone Elastomer in the Medical Self-Care Catalogue. The agency said statements representing the product as "an ideal treatment" after surgery, burns and other trauma exceeded the clearance for keloid scar management, adding that the explanation of how the product works needed supporting data. The company's Internet home page also was faulted for references to FDA.

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Southwest Technologies, North Kansas City, MO, April 17 (CDRH-OC). FDA acknowledged a complaint about another company's promotional activities, stating that the issues merited internal review. The agency then tackled Southwest Technologies' letter, which "included numerous testimonials and letters supporting the use of Elasto-Gel

for off-label uses." The company was informed that the distribution of such reprints was permitted only in response

to unsolicited requests.

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Sybaritic, Bloomington, MN, March 17 (CDRH-OC). After reviewing an ad for the GX-99 Massage Therapy System in "Spa Management Magazine," FDA said claims for cellulite reduction exceeded the device's exemption as a thera-peutic massager. In order to make these claims, the agency said, the company needed to show that they fell within the device's exempted status, file a new 510(k) or petition for the claim's inclusion in the exemption. A related letter was issued to Suburban Ostomy Supply Nov. 5, 1997 (Doc. 6475W).