Originally Published IVD Technology November/December 2005
INDUSTRY NEWS
AdvaMed proposes alterations to ASR guidanceWith the intention of clarifying often-confusing regulations regarding the production and marketing of analyte specific reagents (ASRs), the Advanced Medical Technology Association (AdvaMed; Washington, DC) has submitted a revised list of ASR frequently asked questions to FDA.
The proposal, which builds on AdvaMed's existing ASR document, offers a more detailed definition of so-called "home brews" and explains how they differ from products labeled as "research use only" or "investigational use only." In addition, a much-expanded section provides guidance to laboratories on proper instrumentation and software, and lays out the accountability for validating manufacturer- and laboratory-produced assays. Also included in the proposal is revised language on what is entailed in proper packaging and marketing of ASRs.
"Hopefully the document clarifies the responsibilities of the laboratory and the manufacturer, and considers issues not considered when the rule was first issued," says Carolyn Jones, JD, associate vice president for technology and regulatory affairs at AdvaMed. Jones spearheaded the effort to rewrite the FAQs. "There is an inconsistency in how an ASR is defined in the preamble to the ASR rule and how the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) defines an ASR," she says. "Also, technology has changed and stakeholders are pushing the envelope. FDA has not indicated where it stops."
In recent years, OIVD director Steven Gutman, MD, has expressed a willingness to revisit the ASR issue. In 2003, the office released a guidance document, "Analyte Specific Reagents; Small Entity Compliance Guidance; Guidance for Industry," in an attempt to elucidate its position on marketing issues. Writing in the May 2004 issue of IVD Technology with David Feigal Jr., MD, the former director of the Center for Devices and Radiological Health, Gutman said that the ASR rule, when published in 1997, did not anticipate the complex marketing embraced by industry.
More recently, in June, according to Medical Device & Diagnostic Industry magazine, Gutman reiterated his concerns about ASR guidance at the Orange County Regulatory Affairs (OCRA; Irvine, CA) Discussion Group annual meeting, calling it "an imperfectly written rule" and characterizing ASR marketing as "a dazzling Arabian bazaar of activity." Still, despite FDA's assurances, some industry participants have been dismayed at the slow speed with which the agency has acted.
According to Jones, AdvaMed's motivation for taking on the project was the handful of letters sent by FDA to IVD manufacturers in recent years regarding which products constitute ASRs and which must pass through normal premarket approval (PMA) application channels. Last year, for example, OIVD wrote to Roche Molecular Diagnostics (Pleasanton, CA) and Ventana Medical Systems Inc. (Tucson, AZ) after the companies described respective products they were releasing as ASRs. OIVD suggested that their products were not Class I exempt and asked that they submit PMAs.
At the OCRA meeting, Gutman sounded a hopeful note about AdvaMed's efforts. "We'll take the guidance, probably massage it and make it our own, and attempt to use that as at least a bridge to create some clarity," he said. However, Gutman did offer a few caveats. For instance, he said that FDA would not consider rule changes that render all ASRs Class I exempt products. AdvaMed's proposal acknowledges the importance of Class II and Class III determinations and makes it clear that the final decisions on classification lay with FDA.
"The plan is for FDA to make revisions and issue the FAQs as a draft guidance requiring comments," Jones explains. She says that the comment period will be an important time to solicit further feedback from labs and manufacturers. "I believe there will be some changes and that the subsequent comments will be very interesting. There are some things industry can't agree on, and there are many more where the laboratories do not agree with industry."
More information about the ASR guidance can be obtained from AdvaMed's and OIVD's Web sites at www.advamed.org and www.fda.gov/cdrh/oivd, respectively.
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