The US Food and Drug Administration is proposing to expedite approval of certain medical devices. The agency has issued a draft guidance for a new, voluntary program delineating how the agency intends to accelerate approval of high-risk devices, diagnostics included, that address unmet public health needs. Under the proposed Expedited Access for PreMarket Approval, or EAP, the agency would offer device developers earlier and more interactive engagement with its staff—including the involvement of senior management and greater collaboration on collecting the requisite scientific and clinical data to support approval. Notably, under the EAP, companion diagnostics for a drug reviewed under the accelerated drug approval pathway may be considered for EAP. In a related new draft guidance, the agency addresses pre- and post-market data collection for class III medical devices, which are those with highest risk, to place a greater reliance on post-market collection as a basis for approval, where appropriate. “Both documents illustrate the FDA's continued efforts to work earlier and closer with device developers in order to expedite the introduction of new technologies in the US market,” notes ADVI, a Washington, DC–based healthcare advisory services firm. Manufacturers often turn to the EU, which has fewer hurdles in the regulatory process, for device commercialization.
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