Medical Device Link.

Originally Published IVD Technology April 2003

INDUSTRY NEWS

Richard Park

Christine Tarrajat has been appointed as director general of the European Diagnostics Manufacturers Association (EDMA). She joined EDMA in 1997 as director, and has overseen regulatory affairs and standardization for the association. Tarrajat is a French national and holds degrees in biology as well as industrial and applied microbiology. She has held industry positions in sales, marketing, and strategic planning. Tarrajat replaces John Place, who served as director general of EDMA for eight years.

The Office of In Vitro Diagnostics Devices (OIVD) within the Center for Devices and Radiological Health (CDRH) may reduce premarket trial scrutiny in exchange for increased postmarket vigilance. The limitations of FDA’s premarket review procedures are evident in the current use in 510(k)s of substantial equivalence to products on the market up to thirty years ago. “That was smart regulation in 1982, it was tenable regulation in 1992, but in 2003 that’s not a good scientific place to be,” said OIVD director, Steven Gutman. 

However, some manufacturers are reluctant to be subjected to heavier postmarket vigilance. “Historically, one of our saving features is that FDA hasn’t been as well-connected [and] we’d deal with postmarket people as infrequently as possible,” said Pat Shrader, Becton Dickinson vice president of regulatory affairs and compliance. “Is this going to slow us down, specifically with the decisions we make postmarketing, are we going to have too many decision makers involved, are we going to be reacting in too conservative of a fashion?”

A diagnostic test for severe acute respiratory syndrome (SARS), the flu-like illness that recently struck hundreds of people around the world, has been developed. The illness, originally thought to be a paramyxovirus, is now suspected to be a new type of coronavirus. Officials from the World Health Organization point out that further analyses must be done before the test can be released. Julie Gerberding, MD, director of the Centers for Disease Control and Prevention, expressed reservations about the test’s validity. “It’s very unlikely that you could have a reliable diagnostic when you don’t have an etiology,” she said. However, if it is found to be effective, the test will be made available to doctors in a few weeks and to key laboratories even sooner.

FDA released final guidance, to be effective on May 6, 2003, for antimicrobial susceptibility test systems. These diagnostics are in vitro devices used to assess the antimicrobial susceptibility of bacterial pathogens in less than 16 hours to help determine an appropriate course of treatment. The guidance recommends that essential and category agreement should be greater than 89.9%. It also identifies risks for the antimicrobial testing systems, including the possibility that an inappropriate antimicrobial agent will be administered to a patient, producing no therapeutic benefit if the device delivers an incorrect result. Revisions to FDA’s original draft document, released in 2000, include an acknowledgement of alternatives to colony counts for inoculum density checks such as the use of spectrophometric devices. Additionally, the guidance promotes the use of 501(k)s and “least burdensome” principles. The full text of the guidance can be accessed via the Internet at http://www.fda.gov/cdrh/ode/631.pdf. 

The Cholesterol Reference Method Laboratory Network (CRMLN) has updated its Web site. The Centers for Disease Control and Prevention created the CRMLN to assist manufacturers in calibrating diagnostic test methods used for lipid and lipoprotein testing. The revised site incorporates lists of diagnostic test methods that have been certified through the CRMLN for the measurement of total cholesterol (TC), HDL cholesterol, and LDL cholesterol. It also includes downloadable protocols, a FAQ list, and helpful hints for IVD manufacturers that wish to become certified. The CRMLN Web site is http://www.cdc.gov/nceh/dls/crmln/crmln.htm. 

FDA has released new industry guidance for the use of analyte specific reagents (ASRs) for the development of in-house tests. The guidance describes FDA’s requirements for manufacturers of ASRs and for laboratories that use ASRs. The guidance can be accessed on the Web at http://www.fda.gov/cdrh/oivd/guidance/1205.html.  

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