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news.The Advanced Medical Technology Association (AdvaMed) has formally submitted a proposal to the US Food and Drug Administration (FDA) for a new modernized, risk-based approach to regulate all in vitro diagnostic tests. The Association recommends that FDA consider its proposal for regulating all types of diagnostic tests, regardless of where they are produced. This approach builds upon the strength of the agency’s current regulatory structure and avoids unnecessary duplication of requirements.
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“Diagnostic tests add value to the health care system by enabling more accurate and targeted treatments for patients and by detecting disease earlier when successful treatment can be less costly,” said Vincent Forlenza, president of BD and chair of AdvaMed’s Diagnostic Sector. “Diagnostic tests are the cornerstone of personalized medicine. This proposal will allow patients to benefit sooner from these technologies by modernizing FDA’s regulatory approach so that requirements are applied uniformly and the risks and benefits to patients are considered.”
“AdvaMed’s approach to diagnostic regulation will help promote innovation of new diagnostic technologies and better focus FDA’s limited resources to where they have the greatest public health impact and maintain the agency’s stringent standards of safety and effectiveness,” said Stephen J. Ubl, AdvaMed president and chief executive officer.
Under AdvaMed’s proposal, FDA would apply a risk-based approach to determine the intensity of review for all diagnostic tests while exempting low-risk tests from premarket submission.
To determine the level of regulatory oversight for a diagnostic test, FDA would examine the:
risk associated with clinical use of test
degree of novelty of test’s analyte
degree of novelty of the technology involved, and
site of service/training of the test operator.
In assessing risk, AdvaMed’s proposal recommends FDA consider the following risk-mitigating factor — scientific evidence, general and special controls for medical devices, laboratory process controls, and user experience. By applying a decision model that takes into consideration the risk and the risk mitigation factors, an appropriate level of regulatory oversight can be determined.
“We have consulted with FDA in the development of our proposal, and we look forward to further discussions with the agency,” said Ubl.