Medical Device Link.

Originally Published IVD Technology July 2003

INDUSTRY NEWS

Richard Park

The Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) issued its first warning letter since being established late last year. By sending this letter, OIVD is following through on its commitment to take an active role in the postmarket activities of IVDs.

OIVD issued a warning letter to Applied Imaging Corp. (Santa Clara, CA) for its ariol SL-50, an automated image analysis system. According to the letter, Applied Imaging had made claims in its brochures and on its Web site that this device is for research use only and not for use in diagnostic procedures. However, after reviewing these materials, OIVD concluded that such was not the case. 

“It is clear from the medical and diagnostic claims made for the ariol SL-50 in your promotional materials that this product is not in the research phase of development,” stated Steven Gutman, M.D., the director of OIVD, in the letter.

Gutman continued in the letter that the company “should take prompt action to correct these violations” and “failure to promptly correct these violations may result in regulatory action” by FDA.
Industry analysts believe OIVD’s stance was justifiable and even praised the office for taking such strong action.

“FDA took a hard line but its rationale is clear,” says Katie M. Smith, PhD, senior director of diagnostics clinical research and regulatory affairs at Prometheus Laboratories Inc. (San Diego). “The company was making claims about a research use only (RUO) product when in fact it should be a regulated medical device. This is not allowable per FDA regulations, and Steve Gutman’s office called them on it. It’s kudos to Steve in his new role at FDA. He appears to want to send a message to industry that his office will not tolerate the promotion of unapproved devices, and the warning letter reads loud and clear to this effect.”

At the same time, analysts said that OIVD’s actions were not necessarily novel, but rather emphasized the importance of complying with FDA regulations.

“This situation should not come as a surprise to many companies in the IVD industry,” says Smith. 
“Therefore, it should not negatively affect those companies, or the industry in general for that matter, that are committed to understanding and following FDA regulations that address the promotion of unapproved as well as approved devices. However, those companies that elect not to adhere to FDA regulations run the risk of hearing from FDA in a similar fashion as this situation.”

Other analysts believe IVD companies can learn from this incident by realizing that it is important to be vigilant in how they present their products in their literature. 

“FDA is sending a clear message to the IVD industry concerning products labeled for RUO when the company makes medical and diagnostic claims in its promotional materials,” says Leif E. Olsen, a regulatory affairs specialist at Hogan & Hartson LLP (Washington, DC). “FDA and the IVD industry have struggled with the issue of RUO and investigational use only labeling for many years. This incident emphasizes the importance of the regulatory affairs individuals within IVD companies to understand FDA’s current guidance on this subject and to closely monitor product labeling, which includes sales and marketing literature and Web pages.”

Meanwhile, OIVD is putting together its LabSun pilot program. According to OIVD officials, this program will be an early warning system through which labs will be able to report adverse-event information.

“Once the LabSun pilot is implemented, it will initiate more FDA communication with the IVD industry and initiate targeted inspections specifically to those companies whose products are identified,” says Olsen. “During past meetings, Dr. Gutman has expressed FDA’s desire to focus its energy and resources where they are most needed. As a result, the LabSun program could benefit IVD companies whose products have few quality-related issues.”

Additional information about OIVD can be accessed through its Web site at http://www.fda.gov/cdrh/oivd/index.html 

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