Medical Device Link.

Originally Published IVD Technology June 2004

INDUSTRY NEWS

In March, a letter from the Office of In Vitro Diagnostic Device Regulation and Safety (OIVD) to Ventana Medical Systems Inc. (Tucson, AZ) stated that the company’s Inform HPV test, released by Ventana as an analyte specific reagent (ASR), could not be commercially distributed before the company submitted a premarket approval application (PMA) for the test. Ventana disagreed.

After a meeting between the company and OIVD, Ventana’s HPV test remains on the market as an ASR. 
In its letter, OIVD cited clinical claims made in Ventana’s product literature regarding the relationship between HPV and cervical cancer, and referred to the health risk associated with these claims as reasons for why the test would require a PMA.

Yet, somewhere in the negotiations between Ventana and OIVD, a compromise was reached whereby the test would remain on the market without product changes, but only with changes to the product literature. Neither OIVD nor Ventana was willing to comment on the details of these negotiations.

However, in a letter to his customers, a Ventana representative summarized the company’s negotiations with OIVD, stating, “In response to the FDA recommendations [regarding Ventana’s product claims and promotional practices], we are reviewing our labeling and promotional practices and making any necessary changes.”

Some industry analysts initially suspected that OIVD’s letters to Ventana and to Roche (see “OIVD concludes Roche chip not an ASR,” in the January/February 2004 issue of IVD Technology) marked the beginning of an unwelcome regulatory trend. Jeffrey Gibbs, JD, an expert in regulatory affairs, says, “The part of the letters [from OIVD to Ventana and Roche] that seemed most startling and most concerning was the idea that FDA was going to apply a risk-based approach. I think that FDA is actively reconsidering that, and probably is not going to apply a risk-based approach in the future.”

In addition, some IVD manufacturers may conclude that FDA’s actions reflect the agency’s intention to discourage the release of products as ASRs. However, Gibbs disagrees. “A number of people thought that those letters [from OIVD] signaled major retrenchment in the use of ASRs. I don’t think that’s correct. FDA is not reinterpreting what products are ASRs. It’s not a fundamental reworking of the rule,” he says.

This case has also highlighted the issue of what can appear in the content of product literature and promotional materials for ASRs. To some industry insiders, this issue has been partially addressed by FDA’s recent actions. Gibbs says, “One thing that has become very clear is that companies that make clinical claims for ASRs face the prospect that FDA will not consider the product to be an ASR any longer.”

However, others find that FDA’s actions reveal unanswered questions, and inconsistencies between the ASR regulations and guidance documents. According to Glen Freiberg, a regulatory affairs officer at Gen-Probe (San Diego), “The current OIVD ASR guidance document prohibits product inserts and/or instructions to run a test. However, there’s nothing in any ASR regulations themselves to prohibit such documentation. The question now is, what is FDA going to do to correct the overinterpretation in the ASR guidance, and when is the agency going to correct it?”

Although FDA is not yet able to set a date for when it will answer this question, the agency is working to refine guidance materials for ASRs. When asked when the labeling and other concerns regarding the regulation of ASRs will be resolved, Steven Gutman, MD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety, said, “the ASR regulations and [related] issues are under active evaluation and consideration by FDA, and no final decisions on how to move forward with policies have been determined. We do understand the need for increased clarity in this area and are considering mechanisms for moving forward with this.”

In addition to FDA’s work on refining its industry guidance on ASRs, AdvaMed is working on a revised version of its frequently asked questions (FAQs) document. When the updated FAQs are released, they may provide the IVD industry with its first look at the future of ASR regulations. AdvaMed’s FAQ about ASRs can be accessed via the organization’s Web site at: www.advamed.org/publicdocs/reagents.htm. 

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